System and method for catheter-based intervention

ABSTRACT

Systems and methods for planning delivery of an object via a catheter, such as transseptal delivery of a prosthetic mitral valve to a patient&#39;s heart are disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.18/151,931, filed Jan. 9, 2023, which is a continuation of U.S. patentapplication Ser. No. 16/796,602, filed Feb. 20, 2020, which is acontinuation-in-part of International Application No. PCT/US2019/057295,filed Oct. 21, 2019, which claims priority to Dutch Patent ApplicationNo. 2021849, filed Oct. 22, 2018. The content of each of theapplications is hereby incorporated by reference in its entirety.

BACKGROUND OF THE INVENTION Field of the Invention

This application relates to systems and methods for catheter-basedintervention. In some embodiments, the application more specificallyrelates to systems and methods for planning delivery of an object via acatheter, such as transseptal delivery of a prosthetic mitral valve orleft atrial appendage occlusion device to a patient's heart.

Description of the Related Technology

The human heart is a complex organ having many working parts which arecritical to the proper functioning of the heart to provide bloodcirculation throughout the human body. The human heart is generally madeup of four hollow chambers, the right atrium, the right ventricle, theleft atrium, and the left ventricle. One of the keys to a properlyfunctioning heart is the regulation of blood flow through thesechambers. Regulation of blood flow through and between these chambers isprovided by valves. For example, between the right atrium and the rightventricle, there is an atrioventricular opening.

The tricuspid valve is situated at that opening, and permits blood tomove from the right atrium into the right ventricle. The valve openswhen the blood pressure on the atrium side is greater than that on theventricular side. When the valve opens, blood is permitted to flow fromthe right atrium into the right ventricle. When blood pressure isgreater on the ventricle side, the valve closes. When the valve closes,blood is prevented from moving back in the other direction.

In the healthy heart, blood flow is also regulated between the leftatrium and left ventricle. Here, the mitral valve allows blood to enterthe left ventricle from the left atrium when the left atrium fills withblood and the pressure within the left atrium increases to a level abovethat of the left ventricle. When open, blood flows in a downwarddirection from the left atrium into the left ventricle, where it ispushed out to the rest of the body as part of the greater circulatoryprocess. When a healthy mitral valve closes, blood flow between the twochambers is stopped, and this closing prevents a reversal of blood flow.

Unfortunately, mitral valves do not always function normally. Anabnormally functioning mitral valve can lead to severe health problems.One abnormality associated with the mitral valve is mitral regurgitation(“MR”). Mitral regurgitation is a disorder in which the mitral valvedoes not close properly during contraction of the left ventricle. Thiscauses blood that has passed from the left atrium into the leftventricle to reverse its flow back into the left atrium.

Progressive mitral valve disease may be treated surgically. One surgicaloption includes the replacement of the mitral valve where the mitralvalve is replaced with a prosthetic mitral valve such as a bioprosthetic replacement or a synthetic replacement. Another surgicaloption includes repair of the mitral valve. Although mitral valve repairis generally seen as preferable to mitral valve replacement due to theless invasive nature of the procedure, both options may requireopen-heart surgery. Because many candidates for mitral valve replacementand repair are not good candidates for tolerating the stress ofopen-heart surgery, there has been ongoing research in the field oftranscatheter mitral valve replacement (TMVR). Using TMVR, a prostheticmitral valve can be introduced using a catheter-based system, obviatingthe need for an open-heart surgical procedure.

For example, the prosthetic mitral valve may be placed inside a beatingheart via a catheter at the bottom of the heart through a tube insertedin a small incision in the patient's chest. The physician uses the tubeto deploy the prosthetic mitral valve and positions it so that it restsover the heart's existing mitral valve. Using catheter-based implanttechniques, the physical trauma associated with an open heart surgerymay be minimized and more patients may be treated effectively for themitral regurgitation disorder.

Conventionally, TMVR was performed via thoracotomy and included a directleft atrial and a transapical approach. However, based on a reduction ofrequired sheath size of available prosthetic devices (e.g., a prostheticmitral valve) and delivery systems, a fully percutaneous approach cannow be achieved via the atrial septum, with the valve inserted througheither the jugular or, more frequently, the femoral vein (Dvir, D.,“Transseptal Instead of Transapical Valve Implantation, Making MitralGreat Again?”, in: JACC: Cardiovascular Interventions, Vol. 9, No. 11,2016).

The left atrial appendage (LAA) is a small pouch in the muscle wall ofthe left atrium. Scientists have yet to determine what function, if any,the LAA performs. In normal hearts, with each heart cycle, the heartwill contract and blood will be squeezed out of the left atrium and theLA towards the left ventricle. However, when a patient has atrialfibrillation, the electrical impulses that control the heartbeat do nottravel in an orderly fashion through the heart. Instead, many impulsesbegin at the same time and spread through the atria. The fast andchaotic impulses do not give the atria time to contract and/oreffectively squeeze blood into the ventricles. Because the LAA is alittle pouch, blood collects there and can form clots in the LAA andatria. When blood clots are pumped out of the heart, they can cause astroke.

The risk of a stroke can be mitigated by taking a blood thinner.However, these come with inconvenience for the patient, negative sideeffects and health risks. An alternative is the placement of a leftatrial appendage occlusion device (LAAO). This is a parachute-shapeddevice that is placed at the entrance to the LAA to block any blood flowinto and out of the LAA. The standard way of implanting an LAAO deviceis through a transseptal catheter-based approach. A catheter sheath isinserted into a vein near the groin and guided across the septum(muscular wall that divides the right and left sides of the heart) tothe opening of the LAA. The device is placed in the opening of the LAA.This seals off the LAA and keeps it from releasing clots.

There are different methods of selecting the prosthetic device andplanning its desired position. However, an equally challenging task isthe selection of a delivery system, as not all catheters will be able tofollow a trajectory through the patient's heart suitable to deliver theimplantable device in the selected location.

SUMMARY

Certain embodiments provide a computer-based method of planning acatheter-based intervention, the method comprising: obtaining, at acomputing device, a model of an anatomical region of interest;determining, at the computing device, an entry in the anatomical regionof interest; determining, at the computing device, a target in theanatomical region of interest; determining, at the computing device atrajectory from the entry to the target, the trajectory comprising asequence of a plurality of trajectory segments; and selecting, at thecomputing device, a catheter from a plurality of catheters based on thecatheter being able to achieve the trajectory within at least athreshold.

Certain embodiments provide a computer-based method of planning acatheter-based intervention, the method comprising: obtaining, at acomputing device, a model of an anatomical region of interest;determining, at the computing device, an entry in the anatomical regionof interest; determining, at the computing device, a target in theanatomical region of interest; selecting, at the computing device, oneor more catheters; determining, at the computing device, one or moretrajectories for the one or more catheters from the entry to the targetbased on geometric data about the one or more catheters, each of the oneor more trajectories comprising a sequence of a plurality of trajectorysegments; and selecting, at the computing device, a catheter from theone or more catheters based on the determined one or more trajectories.

Certain embodiments provide a computer-based method of planning acatheter-based intervention, the method comprising: obtaining, by acomputing device, a model of an anatomical region of interest;determining, by the computing device, an entry in the anatomical regionof interest; determining, by the computing device, a target in theanatomical region of interest; determining, by the computing device, atrajectory from the entry to the target, the trajectory comprising asequence of a plurality of trajectory segments, wherein determining afirst trajectory segment of the plurality of trajectory segmentscomprises: obtaining a planned position for an implantable device in theanatomical region of interest; and determining the first trajectorysegment as a line segment that connects a first point on a central axisof a first feature of the anatomical region of interest with a secondpoint on a deployment axis of the positioned implantable device and thatpasses through a geometric center point of a second feature of theanatomical region of interest; and selecting, by the computing device, acatheter from a plurality of catheters based on the catheter being ableto achieve the trajectory within at least a threshold

Certain embodiments provide a computer-based method of planning acatheter-based intervention, the method comprising: obtaining, by acomputing device, a model of an anatomical region of interest;determining, by the computing device, an entry in the anatomical regionof interest; determining, by the computing device, a target in theanatomical region of interest; selecting, by the computing device, oneor more catheters; determining, by the computing device, one or moretrajectories for the one or more catheters from the entry to the targetbased on geometric data about the one or more catheters, each of the oneor more trajectories comprising a sequence of a plurality of trajectorysegments, wherein determining at least one trajectory of the one or moretrajectories comprises determining the at least one trajectory based onone or more constraints, wherein the one or more constraints compriseone or more operational constraints indicating at least one or morepositions within the anatomical region of interest through which the atleast one trajectory should pass and one or more tolerances with respectto the one or more positions within which the at least one trajectoryshould pass; and selecting, by the computing device, a catheter from theone or more catheters based on the determined one or more trajectories.

Certain embodiments provide a computer-based method of planning acatheter-based intervention, the method comprising: obtaining, at acomputing device, a model of an anatomical region of interest;determining, at the computing device, an entry in the anatomical regionof interest; determining, at the computing device, a target in theanatomical region of interest; determining, at the computing device atrajectory from the entry to the target, the trajectory comprising aparametric or piecewise parametric curve, a sequence of straight linesegments, or a combination of curves and line segments; and selecting,at the computing device, a catheter from a plurality of catheters basedon the catheter's pre-bent shape closely matching the trajectory.

Certain embodiments provide a non-transitory computer-readable mediumhaving computer-executable instructions stored thereon, which, whenexecuted by a processor of a computing device, cause the computingdevice to perform the described method.

Certain embodiments provide a computing device comprising a memory and aprocessor configured to perform the described method.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram of one example of a computing environmentsuitable for practicing various embodiments disclosed herein.

FIG. 2 is a high level system diagram of a computing system that may beused in accordance with one or more embodiments.

FIG. 3 illustrates a view of an example 3-D model of a heart.

FIG. 3A illustrates an example of a catheter that includes two locationsof controlled bending.

FIG. 3B illustrates trajectory segments representing a trajectory forthe catheter of FIG. 3A.

FIG. 3C illustrates the use of planes for determining a trajectorysegment.

FIG. 4 illustrates a view of an example 3-D model of a heart.

FIG. 5 illustrates a flow chart showing an example process for planninga catheter-based intervention, according to certain embodiments.

FIG. 6 illustrates a flow chart showing an example process for planninga catheter-based intervention, according to certain embodiments.

FIG. 7 illustrates a view of an example 3-D model of a heart with amodel of an LAAO device in a planned position and control points fordetermining a target trajectory, according to certain embodiments.

FIG. 8 illustrates the determined target trajectory represented as aspline based on FIG. 7 , according to certain embodiments.

FIG. 9 illustrates the determined target trajectory based on FIG. 7 ,according to certain embodiments.

FIG. 10 illustrates a surface model of a catheter with a pre-definedshape along with the determined target trajectory based on FIG. 7 ,according to certain embodiments.

FIG. 11 illustrates the surface model of the catheter of FIG. 10 asregistered to the determined target trajectory based on FIG. 7 ,according to certain embodiments.

FIG. 12 illustrates an ability to rotate the surface model of thecatheter of FIG. 10 as registered to the determined target trajectorybased on FIG. 7 , according to certain embodiments.

FIG. 13 illustrates a flow chart showing an example process for planninga catheter-based intervention, according to certain embodiments.

FIG. 14 illustrates two forms of splines, according to certainembodiments.

DETAILED DESCRIPTION OF CERTAIN INVENTIVE EMBODIMENTS

As noted above, selection of a delivery system for delivering a devicevia a catheter is a challenging task. For example, depending on apatient's anatomy, certain catheters may or may not be used to deliver adevice as each catheter has its own max bend and has either one or twobends at a certain distance from the end/each other. This means that itis possible that the incorrect catheter is selected for delivery of adevice. During a procedure, accordingly, a medical professional may needto change the catheter when it cannot get to the right location duringthe procedure, leading to increased time for the procedure in thecatheter lab, increased radiation for both staff and patient, andincreased waste of materials.

Accordingly, certain embodiments herein provide systems and methods forplanning delivery of an object via a catheter, such as transseptaldelivery of a prosthetic mitral valve or an LAAO device to a patient'sheart. In some embodiments, the systems and methods allow such planningbased on the specific anatomy of the specific patient's heart (i.e.,patient-specific). In certain embodiments, the systems and methods canbe used to see if a certain catheter design (e.g., corresponding to acertain catheter type, model, and/or size) fits the patient anatomy andis thus an option to deliver a device on the location in the heart thatit needs to be deployed in. The systems and methods improve thetechnical field of medicine by allowing for better catheter selection,which can reduce procedure time, leading to less radiation, less wasteof materials, less chance of infection, and improved outcome. Thesystems and methods further improve the functioning of a computingdevice in that it provides a specific method for planning delivery of anobject that reduces computational complexity and use of compute cycles.Further, the systems and methods allow for elimination of the need togenerate physical 3D printed models of anatomy to test catheters. Thesystems and methods can further be used to determine what percentage ofa population that a certain catheter design can statistically be usedfor, or used to develop new catheter designs that work for a largerportion of the population.

In certain embodiments, the systems and methods operate by making adigital model of the anatomy of the patient. A digital model of thedevice is then placed in the digital model of the anatomy of the patientin one or more possible positions (e.g., location+orientation (e.g.,angulation)). For example, a planned position for an implantable device,as in the digital model of the device, may be obtained via input from auser on a computing device, or automatically determined by a computingdevice based on the digital model of the anatomy. The digital model ofthe device may comprise a lifelike 3D virtual model of the device, maycomprise a stylized representation (e.g. comprising one or moreprimitive shapes, such as cylinders, spheres, hemispheres, etc.), or maycomprise an abstract representation, such as a local coordinate system.The placement of the device in the one or more possible positions can beused to determine constraints on the distal end (e.g., furthest pointthe tip/end of the catheter is inserted into the patient) and angulationof the catheter. In certain embodiments, depending on the type ofdevice, there might be some tolerance as to the constraints on thecatheter.

For example, there may be different types of constraints on thecatheter. Capability constraints may be a first type of constraint. Acapability constraint on the catheter, for example, can refer to how farthe catheter can bend, how far it can reach, where it can bend along thecatheter, etc., and is independent of the anatomy in which the catheteris used. In certain aspects, no tolerances are taken into account forsuch capability constraints. Rather, the systems and methods assume thatthe catheter cannot exceed the capability constraints.

Operational constraints are a second type of constraint. Operationalconstraints, for example, can refer to where the catheter should go inthe anatomy during a procedure/operation such as where and in whatdirection the catheter should pass through the anatomy. In certainaspects, tolerances are taken into account for such operationalconstraints. For example, an operational constraint can comprise thecatheter needing to pass through the fossa ovalis (FO). For planningpurposes, the constraint may further be the catheter goes through thecenter of the FO, and that the catheter approaches the FOperpendicularly. However, there may be tolerances for one or more of theposition the catheter passes through the FO (e.g., 1 or 2 mm off-center,within 2 mm from the centerline of the inferior vena cava, etc.) or theapproach the catheter takes (e.g., within 20° of the normal vector tothe FO, etc.).

In further embodiments, the systems and methods then define one ormultiple delivery pathway types (e.g., transseptal through femoral vein,transseptal through subclavian vein, etc.) for inserting the catheterand delivering the device. For example, the systems and methods maydefine specific zones for the catheter to go through (e.g., inferiorvena cava (IVC), fossa ovalis, etc.). Different zones may presentcertain operational constraints (e.g., location, angulation, size, etc.)on the catheter. Different zones may also have different degrees oftolerance as to constraints on the catheter (e.g., bend, curvature,shape, size, endpoint, angulation, etc.).

In further embodiments, the systems and methods fit one or more digitalmodels of one or more catheter designs in the digital model of theanatomy according to the constraints (e.g., operational and/orcapability) on how the catheter can deform (e.g., bends at rightlocation, max curvature, etc.) and output which catheter designs can beused for placing the device in the defined position, using the defineddelivery pathway, for the specific patient anatomy. The output may be ona UI of a computing device, etc. In some embodiments, the systems andmethods automatically select a catheter design.

Though certain embodiments are described with respect to performingtransseptal delivery of prosthetic mitral valves or LAAO devices via theinferior vena cava (IVC) as examples, a person skilled in the art willreadily appreciate that it also applies to other approaches (e.g.transseptal delivery via the superior vena cava, transapical delivery),other catheter-based interventions (e.g., removal of blood clots, tissuecorrection, tissue repair, etc.) or delivery systems for other devices,e.g. in other anatomical parts, etc. In certain embodiments, the systemsand methods are configured for planning the delivery of a prostheticvalve into a patient's heart. In some embodiments, this may morespecifically be the delivery of a prosthetic mitral valve. In someembodiments, this may more specifically be the transseptal delivery of aprosthetic mitral valve, or even more specifically the transseptaldelivery of a prosthetic mitral valve via the IVC or via the superiorvena cava (SVC). In certain embodiments, the systems and methods areconfigured for planning the delivery of an LAAO device into a patient'sheart. In some embodiments, this may more specifically be thetransseptal delivery of an LAAO device, or even more specifically thetransseptal delivery of an LAAO device via the IVC or via the superiorvena cava (SVC). A person skilled in the art will readily appreciatethat all embodiments described herein referencing the IVC also apply,mutatis mutandis, to the SVC. A person skilled in the art will readilyappreciate that all embodiments described herein with respect to thedelivery of a prosthetic valve also apply, mutatis mutandis, to thedelivery of an LAAO device and vice versa.

In certain embodiments, the term “catheter” may refer to anysingle-component or multi-component tube-like system for insertion intoa patient's body to treat diseases or perform a procedure. It may referto any of the objects known in the art as guides, guiding catheters,delivery systems, shafts, sheaths, dilators, diagnostic catheters,micro-catheters, intermediate catheters or combinations of the same.

In certain embodiments, the systems and methods described herein aredescribed with respect to an anatomical region of interest (e.g.,corresponding to one or more anatomical parts) in a static state.However, the systems and methods may also be applicable to anatomicalregions of interest that vary in shape over time. For example, one ormore steps in the methods described herein or performed by the systemsdescribed herein may be repeated for multiple variations of a shape ofan anatomical region over time. For example, if the anatomical region ofinterest is a heart or part of a heart, one or more steps may berepeated for different stages of the heart cycle, e.g., once for thesystole and once for the diastole. In certain embodiments, a cathetermay be selected that the systems and methods find suitable for all ofthe variations in shape (e.g., stages).

In certain embodiments herein, a user, such as a clinician, engineer,technician, medical professional, non-medical user, etc., may operate acomputing device to perform the methods described herein. Further, thecomputing device itself may automatically (in part or fully) perform themethods herein. Further, the systems herein may refer to one or morecomputing devices configured to perform the methods and techniquesdiscussed herein and/or one or more non-transitory computer readablemediums storing instructions to perform the methods and techniquesdiscussed herein.

The systems and methods described herein may be implemented in acomputing environment comprising one or more computing devicesconfigured to provide various functionalities. FIG. 1 is an example of acomputer environment 100 suitable for implementing certain embodimentsdescribed herein. The computer environment 100 may include a network101. The network 101 may take various forms. For example, the network101 may be a local area network installed at a surgical site. In someembodiments, the network 101 may be a wide area network such as theInternet. In other embodiments, the network 101 may be a combination oflocal area networks and wide area networks. Typically, the network willallow for secured communications and data to be shared between variouscomputing devices. Among these computing devices are a client device104. The client device 104 may be a typical personal computer devicethat runs an off-the-shelf operating system such as Windows, Mac OS,Linux, Chrome OS, or some other operating system. The client device 104may have application software installed to allow it to interact via thenetwork 101 with other software stored on various other modules anddevices in the computing environment 100. This application software maytake the form of a web browser capable of accessing a remote applicationservice. Alternatively, the application software may be a clientapplication installed in the operating system of the client device 104.Client device 104 may also take the form of a specialized computer,specifically designed medical imaging work, or even more specificallyfor planning delivery of an object via a catheter, such as transseptaldelivery of a prosthetic mitral valve to a patient's heart. The clientdevice 104 may further take the form of a mobile device or tabletcomputer configured to communicate via the network 101 and furtherconfigured to run one or more software modules to allow a user toperform various methods described herein.

The computer environment 100 may further include database 106.Typically, the database 106 takes the form of a large database. Incertain embodiments, the database 106 is configured to store datapertaining to one or more catheters. The data may include anidentification of each catheter and/or may describe the technicalcapabilities of each catheter. In certain embodiments, the technicalcapabilities comprise one or more of catheter-specific geometricinformation, such as the catheter's dimensions, the locations and shapesof any bends along its length, the locations along its length where thecatheter's operator may control its bending and/or the range of motionand curvature of each of these bends. In certain embodiments, thecatheter-specific information may comprise a virtual 3D model of thecatheter, such as one or more of a surface model, a 3D curverepresenting the catheter's centerline, a radius, or a diameter. Forexample, the database may comprise data relating to one or more deliverysheaths, each with a predetermined shape.

In certain embodiments, the database 106 further stores data pertainingto one or more implantable devices. The data may contain anidentification of each implantable device. In certain embodiments thedatabase 106 further stores compatibility data, describing whichimplantable devices are compatible with which catheters. The data mayfurther contain geometric information, such as the device's shape and/ordimensions, a virtual 3D model of the device, a schematic representationof the device, and/or its deployment axis.

In certain embodiments, the database 106 is configured to store imagefiles received from a medical imaging machine (e.g., scanning device111), a picture archiving and communication system (PACS) system, oranother form of file transfer. For example, the images may be uploadedby the user from a data carrier to a standalone module or a web-basedportal.

These images may be DICOM images, or other types of images such asmedical images of the relevant anatomy, e.g. the patient's heart orportions of the patient's heart, or of a virtual 3D model of therelevant anatomy, e.g. a virtual 3D model of the patient's heart, of aportion of the patient's heart, of the blood pool volume of thepatient's heart or a portion thereof, etc. In certain embodiments,virtual 3D models may be received through any form of file transfer. Forexample, virtual 3D models may be uploaded by the user from a datacarrier to a standalone module or to a web-based portal. In certainembodiments, the client device 104 includes an anatomical data receptionmodule (e.g., a network interface card (NIC)) configured to receive datapertaining to an individual patient's anatomy, such as from database106, via a file transfer, from a medical imaging machine, from a PACSsystem, etc.

In certain embodiments, the database 106 may be part of a scanningdevice 111, or alternatively it may be part of a client computing device104.

The computer environment 100 may also include a scanning device 111. Thescanning device 111 may typically be a medical imaging device whichscans a patient to create images of their anatomy. In the computingenvironment 100 shown in FIG. 1 , the scanning device 111 may be a CTscanner, an MRI device or an ultrasound device. However, a skilledartisan will appreciate that other scanning technologies may beimplemented which provide imaging data that can be used to createthree-dimensional anatomical models.

As will be explained in detail below, the scanning device 111 may beconfigured to create cross-sectional images of a patient's heart. Incertain aspects, those images may be stored in the database 106, andutilized to create three-dimensional models of the heart. To that end,the computing environment 100 may also include an image processingmodule 108 (e.g., a segmentation module). The image processing module108 may take the form of computer software, hardware, or a combinationof both which retrieves medical imaging data (e.g., from database 106)and generates a three-dimensional model using stacks of 2-D image data.The image processing module 108 may be a commercially available imageprocessing software for three-dimensional design and modeling such asthe Mimics application from Materialise NV. However, other imageprocessing software may be used. In some embodiments, the imageprocessing module 108 may be provided via a web-based networkapplication that is accessed by a computer over the network (such asclient device 104, for example). Alternatively, the image processingmodule may be a software application that is installed directly on theclient device 104 (e.g., and accesses database 106 via the network 101).In general, the image processing module 108 may be any combination ofsoftware and/or hardware located within the computing environment 100which provides image processing capabilities on the image data.

In certain embodiments, the image processing module 108 allowsconversion of medical images into one or more virtual 3D models of therelevant anatomy. This process can be automated by means of anyautomatic segmentation method known in the art. Alternatively oradditionally this can be a manual process comprising thresholding,filtering, local mask editing operations, image processing techniquesand the like.

The computing environment also may include a procedure-plan-acquisitionmodule 110. The procedure-plan-acquisition module 110 is configured toallow a user to, or automatically, plan the placement of an implantabledevice. The procedure-plan-acquisition module 110 is further configuredto allow a user to, or automatically, create a plan (referred to as aprocedure plan) based on medical images and/or a virtual 3D model of therelevant anatomy stored in database 106, generated by image processingmodule 108, and/or acquired by the data reception module. In certainembodiments, the procedure-plan-acquisition module 110 is configured togenerate a selection of an implantable device, e.g. selected from thedevices stored in database 106, and its planned position and orientationwithin the patient's anatomy. Alternatively or additionally, theprocedure-plan-acquisition module 110 is configured to receive aprocedure plan from a file. As with the image processing module 108, theprocedure-plan-acquisition module 110 may be a network-based applicationwhich is accessed via a web browser by one or more client devices 104.It may also be a native application installed into the operating systemof a computer, such as client device 104 for example. In still otherembodiments, the procedure-plan-acquisition module 110 may be a networkapplication which is run as a client/server implementation.

The computing environment 100 also may include a landmark-determinationmodule 112. The landmark-determination module 112 is configured to allowa user and/or one or more automatic processes to determine one or moreanatomical landmarks for planning the delivery of the implantabledevice, such as anatomical features, chambers, lumina, surfaces, points,edges, borders, protrusions, indentations, etc., or derived landmarks,such as best-fit planes, centerlines, etc. Automatic processes may beimplemented using any suitable feature-recognition algorithms known inthe art. The landmarks may be indicated manually and/or determinedautomatically on the virtual 3D model of the anatomy and/or on themedical images. In the case of transseptal delivery of a prostheticmitral valve, these landmarks may include one or more of: the inferiorvena cava (IVC) and/or the opening of the IVC; the geometric centerpoint of the opening of the IVC; the central inflow axis of the IVC; thefossa ovalis; the geometric center point of the fossa ovalis; thecentral axis of the fossa ovalis; or the deployment axis of theimplantable device. In the case of transseptal delivery of an LAAOdevice, these landmarks may include one or more of: the inferior venacava (IVC) and/or the opening of the IVC; the geometric center point ofthe opening of the IVC; the central inflow axis of the IVC; the fossaovalis; the geometric center point of the fossa ovalis; the central axisof the fossa ovalis; the ostium of the LAA; the geometric center pointof the ostium of the LAA; the centerline of the LAA; or the deploymentaxis of the implantable device.

The IVC may be indicated, automatically determined and/or stored as a 3Dtubular shape, such as a cylinder, best fitting the section of the IVCclosest to the right atrium.

The opening of the IVC may be indicated, automatically determined and/orstored as a collection of 3D points along its edge (e.g. identified asthe region of highest curvature between the IVC and the right atrium), a3D polyline or a 3D spline curve.

The geometric center point of the opening of the IVC may be indicated,automatically determined and/or stored as the 3D point representing thecenter of gravity of any 3D representation of the opening of the IVC.

The central inflow axis of the IVC may be indicated, automaticallydetermined and/or stored as a 3D line tangential to the centrallongitudinal axis of the IVC at its opening in the right atrium.

The fossa ovalis may be indicated, automatically determined and/orstored as a collection of 3D points, a 3D polyline or a 3D spline curvealong its edge, as a 3D surface or as a 3D volume.

The geometric center point of the fossa ovalis may be indicated,automatically determined and/or stored as the 3D point representing thecenter of gravity of any 3D representation of the fossa ovalis.

The central axis of the fossa ovalis may be indicated, automaticallydetermined and/or stored as a 3D line through the geometric center pointof the fossa ovalis, perpendicular to the best-fit plane through a 3Drepresentation of the fossa ovalis.

The ostium of the LAA may be indicated, automatically determined and/orstored as a collection of 3D points, a 3D polyline or a 3D spline curve(e.g. identified as the region of highest curvature between the rightatrium and the LAA).

The geometric center point of the ostium of the LAA may be indicated,automatically determined and/or stored as the 3D point representing thecenter of gravity of any 3D representation of the ostium of the LAA.

The centerline of the LAA may be indicated, automatically determinedand/or stored as a collection of 3D points, a 3D polyline or a 3D splinecurve running longitudinally along the center of the lumen of the LAA.

In certain embodiments, the deployment axis of the implantable device isthe preferred axis of delivery for the implantable device to be placedin the position and orientation according to the procedure plan. Forexample, the implantable device may be represented in the procedure planas a cylinder with a specific position and orientation in space withrespect to the anatomy. The deployment axis of the implantable device isthen determined as the 3D line running along the central axis of thiscylinder. For example, the implantable device may be represented in theprocedure plan as a virtual 3D model of the device with a specificposition and orientation in space with respect to the anatomy. Thedeployment axis of the implantable device may be given as a 3D line orvector with a fixed position with respect to said virtual 3D model. Incertain embodiments, the position of the deployment axis of theimplantable device with respect to the position of the implantabledevice may be retrieved from database 106.

Other interventions may require a different set of anatomical landmarks.

As with the image processing module 108, the landmark-determinationmodule 112 may be a network-based application which is accessed via aweb browser by one or more client devices 104. It may also be a nativeapplication installed into the operating system of a computer such as,client device 104 for example. In still other embodiments, thelandmark-determination module 112 may be a network application which isrun as a client/server implementation.

The computing environment 100 also may include an execution-planningmodule 114. The execution-planning module 114 is configured to allow theplanning of a delivery trajectory. The delivery trajectory is thetrajectory or a part of the trajectory that a catheter should followthrough the patient's anatomy. The execution-planning module 114 mayallow the choice between different approaches or may allow the user tocompare different approaches (e.g. transapical, transseptal throughfemoral artery, transseptal through subclavian artery, etc.). Forexample, the execution-planning module 114 may allow planning thedelivery of an implantable device from the IVC through the patient'sheart to its planned position and orientation. The execution-planningmodule 114 may be a fully automatic module, a manual module, or asemi-automated module.

In certain embodiments, the execution-planning module 114 takes one ormore of the landmarks determined by the landmark-determination module112 as input.

In certain embodiments, the execution-planning module 114 allows theuser to select, or may automatically determine, one or more tolerances.These tolerances express to what extent a catheter trajectory (deliverytrajectory) may deviate from an ideal trajectory. For example, one suchtolerance may express to what extent the direction of the most distalsection of the catheter may deviate from the direction of the deploymentaxis of the implantable device in its planned position. The tolerancesmay be selected based on the type of intervention, the type of device,the medical condition of the patient, etc.

In certain embodiments, the delivery trajectory may comprise a pluralityof consecutive line segments. For example, the delivery trajectory maycomprise a plurality of consecutive line segments starting at the IVCand ending at the planned location of the implantable device.

In certain embodiments, the number of line segments is determined by thecapabilities of the selected catheter. Many catheters have two locationsof controlled bending along their length. They may therefore only beable to execute a trajectory comprising a maximum of three linesegments: one before the first bend, one between the bends and one afterthe second bend. Catheters with more locations of controlled bending mayexecute trajectories comprising a higher number of line segments. FIGS.3 and 4 illustrate an image of a patient's heart 300. A deliverytrajectory 305 comprising a plurality of line segments 310 and a plannedlocation of an implantable device 315 are shown. It should be noted thatthough certain embodiments describe outputting a schematicrepresentation of a delivery trajectory, in certain embodiments systemsand methods may output (e.g., on a display of a computing device) amodel of a catheter in a patient's anatomy corresponding to theprocedure and/or delivery trajectory. In other embodiments, the numberof line segments is chosen to suit the procedure being planned and theanatomical regions the trajectory has to pass.

It should be understood that though certain embodiments are describedherein using straight line segments as forming a delivery trajectory,curves with control points (e.g., parametric or piecewise parametriccurves, such as splines, Bezier curves, etc.) may additionally oralternatively be used to form a delivery trajectory. For example, adelivery trajectory may be formed as one or more curves with controlpoints to adjust the curvature of each of the one or more curves. Adelivery trajectory may also be formed as a combination of one or morecurves and one or more line segments. For example, line segments may beseparated by curves that mimic the bending of the catheter. In anycombination of curves and/or line segments, the system may enforce1^(st)-order, 2^(nd)-order or 3^(rd)-order continuity betweenconsecutive segments. The term trajectory segments may be used to referto line segments and/or such curve(s) as discussed.

For example, FIG. 3 illustrates a virtual 3D model of a patient's heart300 showing a cut through the patient's heart, revealing both atria andventricles. On the left is the opening of the IVC in the right atrium,indicated by means of a circle 320 (largely obscured). On the right isthe annulus of mitral valve indicated by a 3D spline 330. The plannedposition of a prosthetic mitral valve 315 is indicated by means of acylinder. The planned position may be selected by a user on a computingdevice (e.g., using an input device to define a desired position),determined automatically by the computing device based on the virtual 3Dmodel of the patient's heart 300, etc. The outline of the fossa ovalisis also indicated by means of a 3D spline 340. The trajectory 305 for acatheter for the delivery of the prosthetic mitral valve is indicated asa sequence of three trajectory segments 310 with small spherical handlesat the nodes. In certain aspects, a user may modify the trajectory 305by manipulating the handles. The sequence of trajectory segments 310 mayrepresent any of the trajectories as described herein (e.g., preferredtrajectory, catheter-specific optimal trajectory, catheter'sbest-matching trajectory, any catheter's trajectory). FIG. 4 similarlyillustrates a virtual 3D model of the patient's heart 300.

In certain embodiments, planning the delivery trajectory may comprisedetermining the number of trajectory segments and the lengths,locations, curvatures, and/or directions of each of the plurality oftrajectory segments, and selecting one or more catheters from the devicedatabase that are capable of executing the delivery trajectory. Adistinction may be made between embodiments that involve catheters thatcomprise locations of controlled bending, such as catheters for placingguide wires, and embodiments that involve catheters with apre-determined three-dimensional shape, such as device delivery sheaths.

(A) Catheters with Locations of Controlled Bending

In certain embodiments in which the catheters comprise locations ofcontrolled bending, whether a catheter is capable of executing a givendelivery trajectory depends in part on one or more of the followingthree criteria (e.g., applied using the tolerances described above):

1) The number of trajectory segments may not exceed the catheter'snumber of locations of controlled bending+1.

2) Depending on the design of the catheter, there may be a fixed ormaximum distance between consecutive locations of controlled bending.This distance may set a limit to the length of the correspondingtrajectory segment. Also depending on the design of the catheter, therelationship between the distance between two consecutive locations ofcontrolled bending and the length of the corresponding trajectorysegment may depend on the bending angle, the length of the bend and/orcurvature at one or both of the locations of controlled bending.

For example, FIG. 3A illustrates an example of a catheter 350 thatincludes two locations 355 of controlled bending. Further, FIG. 3Billustrates trajectory segments 310 representing a trajectory 305 forthe catheter 350. In certain aspects, the length of each of the linesegments 305, as shown, depends on the curvature of the adjoining bendsat locations 355. For example, assuming that each bend can beapproximated by a segment of a circle, the length of the correspondingline segment can be computed as:

$L_{segment} = {{B_{1} + D + B_{2}} = {\frac{L_{1}}{\alpha_{1}}.}}$${\tan\left( \frac{\alpha_{1}}{2} \right)} + D + {\frac{L_{2}}{\alpha_{2}}.}$$\tan\left( \frac{\alpha_{2}}{2} \right)$

wherein L₁ and L₂ are the lengths of the bending portions of thecatheter delimiting a straight section, and α₁ and α₂ are the respectiveangles over which those portions are bent.

In other aspects, instead of computing the length of a trajectorysegment 310 based on the curvature of the adjoining bends at locations355, arcs can be used to represent the bends at locations 355 and linesegments used to represent the straight portions of the catheter 350between the arcs.

3) Depending on the design of the catheter, there may be a limit to thetwisting (e.g., torsion around the longitudinal axis between consecutivelocations of controlled bending) and bending (e.g., flexing in a planecomprising the longitudinal axis at a location of controlled bending)angles achievable. These maximal twisting and bending angles may set alimit to the angular degrees of freedom of two or more consecutivetrajectory segments.

In certain embodiments determining the delivery trajectory and selectingthe one or more suitable catheters may follow a trajectory-first or acatheter-first approach.

In certain embodiments, a trajectory-first approach comprises thefollowing three steps:

1) First a number of trajectory segments is selected (e.g., by a user ofthe execution-planning module 114 or automatically by theexecution-planning module 114). In some embodiments, this number may befixed to 3. Other embodiments may allow a free selection of a number of2 or higher. Still other embodiments may determine the number based onwhich catheters are available (e.g., based on data in database 106), andhow many locations of controlled bending they have. In certainembodiments, these embodiments may only consider those catheters thatare compatible with the implantable device selected by theprocedure-plan-acquisition module 110 if compatibility information isavailable in the device database 106. It should be noted that selectionof an implantable device may refer to selection of different types,models, and/or sizes of implantable devices.

2) In a next step, a target trajectory—e.g. a preferred sequence oftrajectory segments—is determined (e.g., by a user of theexecution-planning module 114 or automatically by the execution-planningmodule 114). In an ideal situation, each of the trajectory segmentscomplies with one or more requirements. For example, a first trajectorysegment may start at the IVC and may ideally coincide with the centralinflow axis of the IVC, i.e. it has one endpoint in the center of theopening of the IVC in the right atrium and a direction tangential to thecentral longitudinal axis of the IVC at that point. For example, asecond trajectory segment may ideally perforate the fossa ovalis at thegeometric center point of the fossa ovalis and may ideally be parallelto the central axis of the fossa ovalis. For example, a third trajectorysegment may end at the planned position of the implantable device andmay ideally be parallel to the deployment axis of the implantabledevice. For example, all trajectory segments should be fully containedwithin the blood pool volume of the heart, except for the section wherethe second trajectory segment perforates the fossa ovalis. In a typicalsituation, it may not be possible to reconcile all of theserequirements. The execution-planning module 114 may therefore beconfigured to (e.g., automatically) determine a preferred sequence oftrajectory segments based on an order of priority in which theserequirements may be relaxed and/or a degree to which these requirementsmay be relaxed. For example, the execution-planning module 114 may keepthe end point and the direction of the third trajectory segment fixed.It may prioritize to first relax the requirement of the secondtrajectory segment being parallel to the central axis of the fossaovalis, optionally within a predetermined angular range. It mayprioritize to then relax the requirement of the second trajectorysegment passing through the geometric center point of the fossa ovalis,optionally within a predetermined distance range. It may prioritize tonext relax the requirement of the first trajectory segment beingparallel to the IVC inflow axis, optionally within a predeterminedangular range. It may prioritize to next relax the requirement of thefirst trajectory segment having its starting point in the center of theopening of the IVC, optionally within a predetermined distance range.Requirements may be relaxed until a solution can be found. Theexecution-planning module 114 may use a heuristic approach.Alternatively, the execution-planning module 114 may search for thesequence of trajectory segments that optimizes a certain targetfunction, e.g. the sequence that minimizes a weighted average of how farthe requirements need to be relaxed, or the sequence that minimizes theangles between consecutive trajectory segments. Any suitableoptimization techniques known in the art may be used to optimize thetarget function by the execution-planning module 114. Other prioritiesor combinations of fixed and relaxed requirements are possible. Forexample, the execution-planning module 114 may keep all requirementsfixed except the second trajectory segment being parallel to the centralaxis of the fossa ovalis. As illustrated in FIG. 3C, the secondtrajectory segment may then be determined as the trajectory segment thatconnects a point on the central inflow axis of the IVC 322, representedby a cylinder, with a point on the deployment axis of the implantabledevice 315, represented by a cylinder, and passes through the geometriccenter point 370 of the fossa ovalis, represented by a node. Thistrajectory segment can be determined by constructing a plane 372 throughthe central inflow axis of the IVC 322 and the geometric center point370 of the fossa ovalis, then determining the point 374 at which thedeployment axis of the implantable device 315 intersects this plane 372,then creating a line through this point 374 and the geometric centerpoint 370 of the fossa ovalis, then determining point 376 where thisline intersects the central inflow axis of the IVC and then creating atrajectory segment that connects both intersection points 374 and 376.Alternatively, this trajectory segment can be determined by constructinga plane 378 through the deployment axis of the implantable device 315and the geometric center point 370 of the fossa ovalis, then determiningpoint 376 at which the central inflow axis of the fossa ovalis 322intersects this plane 378, then creating a line through this point 376and the geometric center point 370 of the fossa ovalis, then determiningpoint 374 where this line intersects the deployment axis of theimplantable device 315 and then creating a trajectory segment thatconnects both intersection points 374 and 376. Alternatively, the sameresult can be obtained by constructing a first plane 372 through thecentral inflow axis of the IVC 322 and the geometric center point 370 ofthe fossa ovalis, constructing a second plane 378 through the deploymentaxis of the implantable device 315 and the geometric center point 370 ofthe fossa ovalis, determining the intersection line of these two planes,and creating a trajectory segment 310 between the points where thisintersection line intersects with the central inflow axis of the IVC 322and the deployment axis of the implantable device 315. It should benoted that in certain aspects, such as in the claims, reference to afirst trajectory segment, second trajectory segment, and thirdtrajectory segment may not correspond to an order of trajectory segmentsin a trajectory from entry to target. For example, the second trajectorysegment as described above (e.g., a segment through a septum), mayinstead be referred to as a first trajectory segment. Further, the firsttrajectory segment as described above (e.g., a segment through the rightatrium), may instead be referred to as a second trajectory segment.Further, the third trajectory segment as described above (e.g., asegment through the left atrium), may be referred to as a thirdtrajectory segment.

3) Once the preferred trajectory has been determined, theexecution-planning module 114 may consult the database 106 and determinefor each catheter in the database whether it is able to execute thepreferred trajectory. To determine whether a catheter is able to executethe preferred trajectory, the tolerances described above may be applied.As output, the execution-planning module 114 may deliver a list ofsuitable catheters. Alternatively, the execution-planning module 114 maycompute for each catheter in the database to what extent the trajectorywould have to deviate from the preferred trajectory and assign a scoreto each catheter in the database 106, e.g. as a polynomial function ofthe angles and/or the differences in length between correspondingsections of the preferred trajectory and the catheter's closest-matchingtrajectory. The coefficients of the polynomial function may penalizecertain deviations more than others. As output, the module may deliver alist of catheters, each with a score. The execution-planning module 114may consider only those catheters that are compatible with theimplantable device selected by the procedure-plan-acquisition module 110if compatibility information is available in the database 106.

Further, in certain aspects, as additional output, theexecution-planning module 114 may deliver additional measurementsregarding the preferred trajectory and/or catheter, such as a distancebetween a bend and the FO.

In certain embodiments, a catheter-first approach comprises thefollowing four steps:

1) For each of the catheters in the database 106, the execution-planningmodule 114 may determine one or more possible trajectories, such as fromthe IVC to the planned location of the implantable device, based on thecatheter-specific geometric information stored in the database 106. Theexecution-planning module 114 may consider only those catheters that arecompatible with the implantable device selected by theprocedure-plan-acquisition module 110 if compatibility information isavailable in the database 106. In certain embodiments, theexecution-planning module 114 may determine types of trajectory segmentsto use for the possible trajectories for a given catheter based oncharacteristics of the catheter. For example, locations of controlledbending may occupy a certain length of the catheter. This length can beused to more accurately calculate a trajectory or more accuratelyrepresent a trajectory.

2) The execution-planning module 114 may evaluate each of the possibletrajectories against the requirements described above. For each of therequirements, the trajectory's deviation from the ideal situation may becomputed, e.g. as the angle between the IVC's central inflow axis andthe corresponding section of the catheter, the angle between the fossaovalis' central axis and the corresponding section of the catheter, theangle between implantable device's deployment axis and the correspondingsection of the catheter, the shortest distance between the center of theopening of the IVC and the axis of the catheter, the distance betweenthe geometric center of the fossa ovalis and the point where thecatheter intersects the septum, the distance between center point of theimplantable device and the axis of the most distal section of thecatheter, etc. When computing the deviations, the execution-planningmodule 114 may take into account the tolerances describe above, e.g. byonly counting a deviation when a distance or angular difference exceedsthe corresponding tolerance. A target function may be defined as apolynomial function of these deviations and a catheter-specific optimaltrajectory may be determined by using any suitable optimizing algorithmknown in the art. The execution-planning module 114 may assign a scoreto each catheter-specific optimal trajectory, e.g. based on the value ofthe target function. Limits may be set to the search space, e.g. byimposing maximum values to one or more of the computed deviations,and/or by monitoring that the entire trajectory is entirely containedwithin the blood pool volume of the right and left atrium.

3) In certain embodiments, catheters that are not able to follow atrajectory from the IVC through the fossa ovalis to the planned positionof the implantable device that is entirely contained within the bloodpool volume may be filtered out.

4) As output, the execution-planning module 114 may deliver a list ofeligible catheters, optionally each with a score.

(B) Catheters with a Pre-Determined 3D Shape

In certain embodiments, the catheters may have a pre-determined 3Dshape. More particularly, in certain embodiments, their most distal endmay exhibit one or more pre-determined bends. Examples include certaindevice delivery sheaths. In certain embodiments, such sheaths areflexible enough to be led over a guidewire from the incision to theimplantation site. However, in certain embodiments, their pre-determinedshape has the purpose to keep them in position even after removal of theguidewire and to facilitate correct device placement.

In certain embodiments determining the delivery trajectory and selectingthe one or more suitable catheters may comprise the following two steps:

1) First, a target trajectory—e.g. a preferred parametric curve,piecewise parametric curve or sequence of trajectory segments—isdetermined (e.g., by a user of the execution-planning module 114 orautomatically by the execution-planning module 114). This targettrajectory may comply with one or more requirements. For example, thetarget trajectory or a first trajectory segment may start at the IVC andmay be tangential to the central inflow axis of the IVC, i.e. it has oneendpoint in the center of the opening of the IVC in the right atrium anda direction tangential to the central longitudinal axis of the IVC atthat point. For example, the target trajectory or a second trajectorysegment may perforate the fossa ovalis at the geometric center point ofthe fossa ovalis and may be parallel at the perforation point to thecentral axis of the fossa ovalis. For example, the target trajectory ora third trajectory segment may end at the planned position of theimplantable device and may be parallel at its end point to thedeployment axis of the implantable device. Alternatively, the trajectoryor a third trajectory segment may end at the geometric center point ofthe ostium of the LAA and may be parallel at its end point to thecenterline of the LAA. For example, the entire trajectory or alltrajectory segments should be fully contained within the blood poolvolume of the heart, except for the section where the second trajectorysegment perforates the fossa ovalis. The target trajectory may bedetermined automatically based on one or more landmarks determined bythe landmark determination module 112 or may be manually indicated bythe user.

FIG. 7 illustrates a view of an example 3-D model 700 of a part of aheart with a model of an LAAO device 706 in a planned position and knots708 for determining a target trajectory, according to certainembodiments. FIG. 7 illustrates a right atrium 701, a left atrium 702, aLAA 703, a FO 704, an opening of the IVC 705, a planned deploymentdirection 707 of the LAAO device 706, and spline knots 708 a-708 e. Forexample, as illustrated in FIG. 7 , in the case of the placement of anLAAO device 706, the target trajectory may be determined as a 3D splinecurve with a knot in the geometric center point of the opening of theIVC 708 a, a knot in the geometric center point of the FO 708 b and aknot in the planned location of the LAAO device 708 c. Additional knotsmay be used to control the direction of the spline curve at one or moreof these locations. For example, the direction of the spline at thegeometric center point of the opening of the IVC can be madesubstantially parallel to the central inflow axis of the IVC by adding aknot 708 d at a certain distance from the center point of the opening ofthe IVC—such as a distance between 1 cm and 3 cm, such as 2 cm—in theopposite direction, i.e. into the IVC. Similarly, the direction of thespline at the planned location of the LAAO device can be madesubstantially parallel to the deployment direction of the device byadding a knot 708 e at a certain distance from the planned location ofthe LAAO device—such as a distance between 1 cm and 3 cm, such as 2cm—in the deployment direction. FIG. 8 shows the resulting spline 709representing the target trajectory. One or more types of parametric andpiecewise parametric curves can be used with embodiments herein, such assplines, Bezier splines, B-splines and/or non-uniform rational B-splines(NURBS), and various definitions and implementations are known in theart, as is illustrated in FIG. 14 , showing two identical splines 1400and 1410, according to an example. Spline 1400 is defined by means of asequence of control points 1401 a-g. Spline 1410 is defined by means ofa combination of knots 1411 a-d and control points 1412 a-f. A personskilled in the art will readily understand that any of these definitionsmay be used to obtain similar results. For example, the direction of thespline at the geometric center point of the opening of the IVC can bemade substantially parallel to the central inflow axis of the IVC byadding a control point at a certain distance from the center point ofthe opening of the IVC—such as a distance between 1 cm and 3 cm, such as2 cm—in a direction parallel to the central inflow axis into the rightatrium. A similar result may also be obtained with a sequence ofstraight line segments, with a sequence of curves, such as arcs,parametric curves or piecewise parametric curves, or with a combinationof straight line segments and curves. The result of this first step is apreferred trajectory.

2) Once the preferred trajectory has been determined, theexecution-planning module 114 may consult the database 106 and determinefor each catheter in the database how well its pre-determined shapematches the preferred trajectory. Different approaches are possible. Forexample, if database 106 contains for each catheter geometricinformation of the centerline of at least its distal part, theexecution-planning module 114 may register this centerline onto thepreferred trajectory. A first plurality of points may be defined atregular intervals, to begin with the catheter's distal end. A secondplurality of points may be defined at identical intervals, to begin withthe planned location of the LAAO device. Next the first and secondpluralities may be registered by means of any rigid point setregistration algorithm known in the art. Alternatively, if database 106contains for each catheter geometric information regarding thecatheter's outer surface and diameter (or radius), a virtual tube may becreated by sweeping a circle with the same diameter along the preferredtrajectory. For example, FIG. 9 shows the resulting target trajectory902, which is shown by sweeping the spline 709 with a circle to producea tubular surface. Next, the surface model of the catheter may beregistered onto the swept surface. For example, Figure illustrates asurface model of a catheter 1002 with a pre-defined shape. For example,FIG. 11 illustrates the surface model of the catheter 1002 registered tothe resulting target trajectory 902. For each catheter, theexecution-planning module 114 may compute whether the deviation betweenthe registered centerline or surface model and the preferred trajectoryor swept surface, respectively, falls within set tolerances. As output,the execution-planning module 114 may deliver a list of suitablecatheters. Alternatively, the execution-planning module 114 may assignto each catheter in the database 106 a score based on said deviation. Asoutput, the module may deliver a list of catheters, each with a score.The execution-planning module 114 may consider only those catheters thatare compatible with the implantable device selected by theprocedure-plan-acquisition module 110 if compatibility information isavailable in the database 106. Alternatively or additionally, theexecution-planning module may display the catheter's registeredcenterline or surface model onto a depiction as described below andallow the user to visually assess the suitability of the particularcatheter.

Further, in certain aspects, as additional output, theexecution-planning module 114 may deliver additional measurementsregarding the preferred trajectory and/or catheter, such as a distancebetween the registered centerline and the center of the FO.

In certain embodiments, the execution-planning module 114 presents oneor more of any of the trajectories mentioned above (e.g., both targettrajectories and catheter-specific trajectories) in a visualrepresentation of the anatomy. The visual representation may compriseone or more depictions of the medical images and/or a virtual 3D modelof the relevant anatomy stored in database 106, generated by imageprocessing module 108, and/or acquired by the data reception module. Thevisual representation may comprise any combination of 2D and/or 3D viewsachieved through displaying of image data, volume rendering or surfacerendering. The execution-planning module 114 may compriseaugmented-reality or virtual-reality capabilities for presenting thetrajectories to a user. The execution-planning module 114 may allow theuser to specify viewing directions or may impose predefined viewingdirections. In certain aspects, the execution-planning module 114, asdiscussed, further presents additional measurements in the visualizationsuch as regarding the preferred trajectory and/or catheter, such as adistance between a bend and the FO. In certain aspects, theexecution-planning module 114, as discussed, further presents a model ofa catheter in a patient's anatomy corresponding to the procedure and/ordelivery trajectory in the visualization.

The execution-planning module 114 may present a trajectory by means oftrajectory segments (e.g. shown as solid, dashed or dotted 2D lines,curves, cylinders, tubes or the like), optionally connected by nodes(e.g. shown as circles, squares, diamonds, spheres, cubes, etc.). At anystep in the process, the execution-planning module 114 may allow theuser to interactively move nodes or trajectory segments in the visualrepresentation. The execution-planning module 114 may limit thismovement in any appropriate way or make other parts of the trajectorymove along with it (e.g. such that the trajectory remains contained inthe blood pool volume of the atria, such that the trajectory alwayspasses through the fossa ovalis, such that the trajectory requirementsdo not have to be overly relaxed, such that a catheter-specifictrajectory remains within the capabilities of the catheter, etc.). Forcatheters with a pre-defined shape, the limitation of the movement maydictate that this shape stay constant, i.e. the movement represent arigid transformation. Additional limitations may be possible. Forexample, the execution-planning module 114 may only allow the user torotate the representation of the catheter around the inflow axis of theIVC, or may limit translation to within the boundaries of the opening ofthe IVC. For example, FIG. 12 illustrates how the surface model of thecatheter 1002 may be rotated around the inflow axis of the IVC 1202. Incertain aspects, the execution-planning module 114 may present atrajectory by means of a model of a catheter in a patient's anatomycorresponding to the procedure and/or delivery trajectory.

In certain embodiments, the execution-planning module 114 allows theuser to select one of the proposed catheters. Alternatively, the usermay decide to return to the procedure-plan-acquisition module 110 toevaluate a different implantable device and/or a different locationand/or orientation of the implantable device and re-iterate the process.

As with the image processing module 108, the execution-planning module114 may be a network-based application which is accessed via a webbrowser by one or more client devices 104. It may also be a nativeapplication installed into the operating system of a computer, such asclient device 104 for example. In still other embodiments, theexecution-planning module 114 may be a network application which is runas a client/server implementation.

The computing environment also may include an output module 116. Incertain embodiments, the optional output module 116 is configured toexport the execution plan and/or the procedure plan to a file, or to anintra-operative guidance system. Such a guidance system may overlay theplanned trajectory and/or planned location and orientation of theimplantable device onto images captured during the intervention, it mayprovide visual, audible and/or force feedback to the person operatingthe catheter, or it may robotically steer the catheter along the plannedtrajectory. The output module 116 may comprise augmented-reality orvirtual-reality capabilities for presenting the trajectories to a user.The execution plan may comprise data regarding the selected catheterand/or 3D data of the relevant anatomy and the trajectory of thecatheter through the anatomy.

As with the image processing module 108, the output module 116 may be anetwork-based application which is accessed via a web browser by one ormore client devices 104. It may also be a native application installedinto the operating system of a computer such as, client device 104 forexample. In still other embodiments, the output module 116 may be anetwork application which is run as a client/server implementation.

Various embodiments of the invention may be implemented using generaland/or special purpose computing devices. Turning now to FIG. 2 , anexample of a computing device 200 suitable for implementing variousembodiments of the invention is shown. The computer system 200 maygenerally take the form of computer hardware configured to executecertain processes and instructions in accordance with variousembodiments of one or more embodiments described herein. The computerhardware may be a single computer or it may be multiple computersconfigured to work together. The computing device 200 includes aprocessor 202. The processor 202 may be one or more standard personalcomputer processor such as those designed and/or distributed by Intel,Advanced Micro Devices, Apple, or ARM. The processor 202 may also be amore specialized processor designed specifically for image processingand/or analysis. The computing device 200 may also include a display204. The display 204 may be a standard computer monitor such as, an LCDmonitor as is well known. The display 204 may also take the form of adisplay integrated into the body of the computing device, for example aswith an all-in-one computing device or a tablet computer.

The computing device 200 may also include input/output devices 206.These may include standard peripherals such as keyboards, mice,printers, and other basic I/O software and hardware. The computingdevice 200 may further include memory 208. The memory 208 may takevarious forms. For example, the memory 208 may include volatile memory210. The volatile memory 210 may be some form of random access memory,and may be generally configured to load executable software modules intomemory so that the software modules may be executed by the processor 202in a manner well known in the art. The software modules may be stored ina nonvolatile memory 212. The non-volatile memory 212 may take the formof a hard disk drive, a flash memory, a solid state hard drive or someother form of non-volatile memory. The non-volatile memory 212 may alsobe used to store non-executable data, such database files and the like.

The computer device 200 also may include a network interface 214. Thenetwork interface may take the form of a network interface card and itscorresponding software drivers and/or firmware configured to provide thesystem 200 with access to a network (such as the Internet, for example).The network interface card 214 may be configured to access variousdifferent types of networks, such as those described above in connectionwith FIG. 2 . For example the network interface card 214 may beconfigured to access private networks that are not publicly accessible.The network interface card 214 may also be configured to access wirelessnetworks such using wireless data transfer technologies such as EVDO,WiMAX, or LTE network. Although a single network interface 214 is shownin FIG. 2 , multiple network interface cards 214 may be present in orderto access different types of networks. In addition, a single networkinterface card 214 may be configured to allow access to multipledifferent types of networks.

In general, the computing environment 100 shown in FIG. 1 may generallyinclude one, a few, or many different types of computing devices 200which work together to carry out various embodiments described below.For example, the computing device 200 may correspond to client device104. Further, the modules of FIG. 1 may correspond to one or morecomputing devices 200 (e.g., run on one or more computing devices 200).A skilled artisan will readily appreciate that various different typesof computing devices and network configurations may be implemented tocarry out the inventive systems and methods disclosed herein.

FIG. 5 illustrates a flow chart showing an example process 500 forplanning a catheter-based intervention. It should be noted that incertain embodiments, process 500 is a computer-implemented process(e.g., by computing environment 100, computing device 200, etc.).Further, certain blocks may be performed automatically, manually by auser of a computing device, or partially manually and partiallyautomatically such as based on input from a user of a computing device.

Process 500 begins at block 502, where the computing device visualizes(e.g., displays) one or more depictions of an anatomical region ofinterest. For example, the computing device generates a digital model ofthe anatomical region of interest. Continuing, at block 504, thecomputing device determines an entry for the catheter. Further, at block505, the computing device determines a target for the catheter.Continuing, at block 508, the computing device determines a preferredtrajectory for a catheter from the entry to the target. Further, atblock 510, the computing device generates, based on the preferredtrajectory, an execution plan.

FIG. 6 illustrates a flow chart showing an example process 600 forplanning a catheter-based intervention. It should be noted that incertain embodiments, process 600 is a computer-implemented process(e.g., by computing environment 100, computing device 200, etc.).Further, certain blocks may be performed automatically, manually by auser of a computing device, or partially manually and partiallyautomatically such as based on input from a user of a computing device.

Process 600 begins at block 602, where the computing device visualizes(e.g., displays) one or more depictions of an anatomical region ofinterest. For example, the computing device generates a digital model ofthe anatomical region of interest. Continuing, at block 604, thecomputing device determines an entry for the catheter. Further, at block606, the computing device determines a target for the catheter.Continuing, at block 608, the computing device selects from a databaseone or more catheters suitable/eligible for the catheter-basedintervention. Further, at block 610, for each of the one or morecatheters, the computing device determines a trajectory from the entryto the target. Further, at block 612, the computing device generates,based on the one or more trajectories, an execution plan.

FIG. 13 illustrates a flow chart showing an example process 1300 forplanning a catheter-based intervention. It should be noted that incertain embodiments, process 1300 is a computer-implemented process(e.g., by computing environment 100, computing device 200, etc.).Further, certain blocks may be performed automatically, manually by auser of a computing device, or partially manually and partiallyautomatically such as based on input from a user of a computing device.

Process 1300 begins at block 1302, where the computing device visualizes(e.g., displays) one or more depictions of an anatomical region ofinterest. For example, the computing device generates a digital model ofthe anatomical region of interest.

Process 1300 continues at block 1304 by determining, at the computingdevice, an entry in the anatomical region of interest.

Process 1300 continues at block 1306 by determining, at the computingdevice, a target in the anatomical region of interest.

Process 1300 continues at block 1308 by determining, at the computingdevice a trajectory from the entry to the target, the trajectorycomprising a parametric or piecewise parametric curve, a sequence ofstraight line segments, or a combination of curves and line segments.

Process 1300 continues at block 1310 by selecting, at the computingdevice, a catheter from a plurality of catheters based on the catheter'spre-bent shape (e.g., best, within a threshold, etc.) matching thetrajectory.

Process 1300 continues at optional block 1312 by generating, based onthe selected catheter, an execution plan.

In some embodiments, the processes 500 and/or 600 and/or 1300 may becomputer-implemented methods. The processes 500 and/or 600 and/or 1300may be wholly or partly performed by a computing device, a medicalpractitioner, and/or a non-medical user, such as an engineer ortechnician.

In some embodiments, the anatomical region of interest may be the heartof a patient, a part of the heart of a patient, and/or the blood poolvolume of the heart of a patient or a part of the heart of a patient,such as the right and left atria and/or the LAA.

In some embodiments, the entry may be the IVC, the opening of the IVC inthe right atrium or a point within the opening of the IVC in the rightatrium, such as its geometric center point.

In some embodiments, the catheter-based intervention may be the deliveryof an implantable device and the target may be a planned position of theimplantable device in the anatomical region of interest. In someembodiments, the implantable device may be a prosthetic mitral valve,and the planned position of the implantable device may be a location andorientation of the prosthetic mitral valve within the mitral valve ofthe patient. In some embodiments, the implantable device may be an LAAOdevice, and the planned position of the implantable device may be alocation and orientation of the LAAO device within the LAA of thepatient

In some embodiments, the one or more depictions of the anatomical regionof interest may be 2D and/or 3D visualizations. These may, amongstothers, be medical images, volume renderings of medical images, virtual3D models or combinations thereof.

In some embodiments, visualizing one or more depictions (e.g., block 502and/or 602 and/or 1302) comprises showing the depictions on a screen ofa computing device.

In some embodiments, visualizing one or more depictions of an anatomicalregion of interest (e.g., block 502 and/or 602 and/or 1302) may furthercomprise receiving data pertaining to the anatomical region of interest.The data may take the form of medical images of the anatomical region ofinterest, e.g. the patient's heart or portions of the patient's heart,or of a virtual 3D model of the anatomical region of interest. Medicalimages may be received from a medical imaging machine, a PACS system, oranother form of file transfer. For example, the images may be uploadedby the user from a data carrier to a standalone module or a web-basedportal. Virtual 3D models may be received through any form of filetransfer. For example, virtual 3D models may be uploaded by the userfrom a data carrier to a standalone module or to a web-based portal.

In some embodiments, visualizing one or more depictions of an anatomicalregion of interest (e.g., block 502 and/or 602 and/or 1302) may furthercomprise converting medical images into one or more virtual 3D models ofthe relevant anatomy. This process can be automated by means of anyautomatic segmentation method known in the art. Alternatively oradditionally this can be a manual process comprising thresholding,filtering, local mask editing operations, image-processing techniquesand the like. For example, the Mimics software by Materialise can beused for this process.

In some embodiments, determining an entry (e.g., block 504 and/or 604and/or 1304) may comprise determining a point of entry at which atrajectory of a catheter is to enter the anatomical region of interest.Alternatively or additionally, it may comprise determining an areawithin the anatomical region of interest within which a point of entryshould be located. In some embodiments, determining an entry may furthercomprise determining an entry direction, e.g. a direction to which atrajectory of a catheter should be parallel as it enters the anatomicalregion of interest.

In some embodiments, an entry may be determined by manually indicatingit on one or more of the one or more depictions of the anatomical regionof interest.

In some embodiments, determining an entry may comprise identifying inthe data pertaining to the anatomical region of interest one or moreanatomical landmarks. Anatomical landmarks may be identified manually orautomatically by means of any feature-recognition methods known in theart. Anatomical landmarks may be individual points, lines, curves orareas in the anatomical region of interest that may serve to define anentry. For example, the opening of the IVC in the right atrium may beidentified as an area within which the point of entry should be located.For example, the geometric center of the opening of the IVC in the rightatrium may be identified as the point of entry. For example, thecenterline of the section of the IVC closest to the right atrium may beidentified to determine the entry direction.

In some embodiments, determining an entry may further comprisevisualizing the entry in one or more of the one or more depictions ofthe anatomical region of interest. This may comprise overlaying onto oneor more of the one or more depictions a visual marker, such as a dot, acircle, a disk, a square, a diamond or the like to indicate a singlepoint of entry. Additionally or alternatively, it may compriseoverlaying onto one or more of the one or more depictions a visualmarker, such as a closed polyline, a closed curve, a closed splinecurve, a colored transparent, semitransparent or opaque shape, a hatchedshape or the like to indicate an area or region within which a suitablepoint of entry may be located. For example, the opening of the IVC inthe right atrium may be visualized on a virtual 3D model of the bloodpool volume of the right atrium as the area comprising all suitablepoints of entry by means of a polyline around its circumference. Anentry direction may be visualized by overlaying onto one or more of theone or more depictions a visual marker, such as a trajectory segment, asolid line, a dotted line, a dashed line, optionally with a marker atone of its endpoints, such as an arrow, a dot, a square or the like.

In some embodiments, determining an entry (e.g., block 504 and/or 604and/or 1304) may further comprise manually editing the entry, the pointof entry, the area of entry and/or the entry direction. This may, forexample, be achieved by means of interactively moving one or part of anyof the visual markers described above.

In some embodiments, determining a target (e.g., block 505 and/or 606and/or 1306) may comprise determining a target point at which atrajectory of a catheter is to terminate. Alternatively or additionally,it may comprise determining an area within the anatomical region ofinterest within which a target point should be located. In someembodiments, determining a target may further comprise determining atarget direction, e.g. a direction to which the final section of atrajectory of a catheter should be parallel.

In some embodiments, a target may be determined by manually indicatingit on one or more of the one or more depictions of the anatomical regionof interest.

In some embodiments, determining a target may comprise identifying inthe data pertaining to the anatomical region of interest one or moreanatomical landmarks. Anatomical landmarks may be identified manually orautomatically by means of any feature-recognition methods known in theart. Anatomical landmarks may be individual points, lines, curves orareas in the anatomical region of interest that may serve to define atarget. For example, the annulus of the mitral valve may be identifiedas an area within which the target point should be located. For example,the geometric center of the annulus of the mitral valve may beidentified as the target point. For example, the normal vector of theplane best fitting the mitral valve's annulus may be identified todetermine the target direction. For example, the ostium of the LAA maybe identified as an area within which the target point should belocated. For example, the geometric center of the ostium of the LAA maybe identified as the target point. For example, the centerline of theLAA's lumen may be identified to determine the target direction.

In some embodiments, determining a target may comprise visualizing it inone or more of the one or more depictions of the anatomical region ofinterest. A target may be visualized by overlaying onto one or more ofthe one or more depictions a visual marker, such as a dot, a circle, adisk, a square, a diamond or the like to indicate a single point.Additionally or alternatively, it may comprise overlaying onto one ormore of the one or more depictions a visual marker, such as a closedpolyline, a closed curve, a closed spline curve, a colored transparent,semitransparent or opaque shape, a hatched shape or the like to indicatean area or region within which a suitable target may be located.Additionally or alternatively, it may comprise overlaying onto one ormore of the one or more depictions a visual marker, such as a trajectorysegment, a solid line, a dotted line, a dashed line, optionally with amarker at one of its endpoints, such as an arrow, a dot, a square or thelike, to indicate a direction in which the catheter should reach thetarget.

In some embodiments, determining a target may further comprise manuallyediting the target. This may, for example, be achieved by means ofinteractively moving one or part of any of the visual markers describedabove.

Additionally or alternatively, in those cases where the catheter-basedintervention is the delivery of an implantable device, visualizing atarget may further comprise visualizing the implantable device in itsplanned position. For example, a prosthetic mitral valve may bevisualized in a virtual 3D model of the native mitral valve as acylinder or as a virtual 3D model of the prosthetic device. A targetpoint may further be visualized by means of a dot or a sphere on thevalve's deployment axis. A target direction may further be visualized bymeans of a line parallel to the valve's deployment axis. For example, anLAAO device may be visualized in a virtual 3D model of the LAA as acylinder or as a virtual 3D model of the LAAO device. A target point mayfurther be visualized by means of a dot or a sphere on the device'sdeployment axis. A target direction may further be visualized by meansof a line parallel to the device's deployment axis.

In some embodiments in which the catheter-based intervention is thedelivery of an implantable device, determining the target may furthercomprise loading and/or visualizing a virtual 3D model of theimplantable device from a file, database, library, network location ordata carrier. Additionally or alternatively, it may comprise loading aprocedure plan from a file, network location or data carrier. Such aprocedure plan may comprise data concerning the device to be implanted,such as its type, brand and/or size, and its planned location andorientation with respect to the patient's anatomy.

In some embodiments, determining a target may further comprise manuallydesignating and/or editing the planned position of an implantabledevice, e.g. its location and/or orientation with respect to thepatient's anatomy. This may, for example, be achieved by means ofinteractively moving the visual representation of the implantabledevice, and/or one or more visual markers attached to it. Target pointand/or target direction may follow the changes made to the plannedposition of the implantable device.

In some embodiments, processes 500 and/or 600 and/or 1300 for planning acatheter-based intervention may further comprise an additional block(e.g., after block 505/606/1306 and before block 508/608/1308) ofdetermining one or more local passages. The additional block maycomprise identifying in the data pertaining to the anatomical region ofinterest one or more anatomical landmarks. Anatomical landmarks may beidentified manually or automatically by means of any feature-recognitionmethods known in the art. Anatomical landmarks may be individual points,lines, curves or areas in the anatomical region of interest that mayserve to define local points and/or directions of passage for thetrajectory. For example, the boundary of the fossa ovalis may beidentified as the boundary of an area through which the trajectoryshould pass. For example, the geometric center of the fossa ovalis maybe identified as a point through which the trajectory should pass. Forexample, the normal vector of the plane best fitting the fossa ovalismay be identified to determine a direction to which the trajectoryshould locally be parallel.

In some embodiments, determining a local passage may comprisevisualizing it in one or more of the one or more depictions of theanatomical region of interest. A local passage may be visualized byoverlaying onto one or more of the one or more depictions a visualmarker, such as a dot, a circle, a disk, a square, a diamond or the liketo indicate a single point. Additionally or alternatively, it maycomprise overlaying onto one or more of the one or more depictions avisual marker, such as a closed polyline, a closed curve, a closedspline curve, a colored transparent, semitransparent or opaque shape, ahatched shape or the like to indicate an area or region within which asuitable local passage may be located. Additionally or alternatively, itmay comprise overlaying onto one or more of the one or more depictions avisual marker, such as a trajectory segment, a solid line, a dottedline, a dashed line, optionally with a marker at one of its endpoints,such as an arrow, a dot, a square or the like, to indicate a directionto which the catheter should be parallel as it passes the local passage.

In some embodiments, determining a local passage may further comprisemanually editing the local passage. This may, for example, be achievedby means of interactively moving one or part of any of the visualmarkers described above.

In some embodiments, block 508 of determining a preferred trajectory fora catheter from the entry to the target may comprise determining atrajectory as a sequence of one or more trajectory segments through theanatomical region of interest from the entry to the target. The numberof trajectory segments can be chosen freely by the user or can be apredetermined number, such as, for example, 3 or any other whole number.The number may depend on the type of catheter-based intervention or thetypes of available catheters. For example, if only catheters areavailable with n locations of controlled bending, the number oftrajectory segments may be set at n+1.

If the determined entry defines a single point of entry, the firsttrajectory segment may have a starting point coinciding with or close tothe point of entry. If the determined entry defines an area, the pointof entry may be a point within that area. If the determined entry alsodefines an entry direction, the first trajectory segment may be parallelor substantially parallel to the entry direction.

If the determined target defines a single point, the final trajectorysegment may have an end point coinciding with or close to the targetpoint. If the determined target defines an area, the end point may be apoint within that area. If the visualized target also defines a targetdirection, the final trajectory segment may be parallel or substantiallyparallel to the target direction.

In some embodiments, determining a preferred trajectory for a catheterin block 508 comprises determining a contiguous sequence of trajectorysegments. There may be one or more requirements or constraints withwhich, in an ideal situation, the sequence of trajectory segmentscomplies. For example, the first trajectory segment may start at adetermined entry point and be parallel to a determined entry direction,the final trajectory segment may end at a determined target point and beparallel to a determined target direction, and one or more intermediatetrajectory segments may pass through identified local points of passageand/or be parallel to identified local directions of passage. Forexample, a first trajectory segment may start at the IVC and may ideallycoincide with the central inflow axis of the IVC, e.g. it has oneendpoint in the center of the opening of the IVC in the right atrium anda direction tangential to the central longitudinal axis of the IVC atthat point. For example, a second trajectory segment may ideallyperforate the fossa ovalis at the geometric center point of the fossaovalis and may ideally be parallel to the central axis of the fossaovalis, e.g. the axis through the geometric center of the fossa ovalisand parallel to the normal vector to the plane best fitting the fossaovalis. For example, a third trajectory segment may end at the plannedposition of an implantable device and may ideally be parallel to thedeployment axis of the implantable device. For example, all trajectorysegments should be fully contained within the blood pool volume of theheart, except for the section where the second trajectory segmentperforates the fossa ovalis.

In a typical situation, it may not be possible to reconcile all of theserequirements. Determining a preferred trajectory may therefore be basedon an order of priority in which these requirements may be relaxedand/or a degree to which these requirements may be relaxed. For example,the process 500 may keep the end point and the direction of the finaltrajectory segment fixed. It may prioritize to first relax therequirement of the second trajectory segment being parallel to thecentral axis of the fossa ovalis, optionally within a predeterminedangular range. It may prioritize to then relax the requirement of thesecond trajectory segment passing through the geometric center point ofthe fossa ovalis, optionally within a predetermined distance range. Itmay prioritize to next relax the requirement of the first trajectorysegment being parallel to the IVC inflow axis, optionally within apredetermined angular range. It may prioritize to next relax therequirement of the first trajectory segment having its starting point inthe center of the opening of the IVC, optionally within a predetermineddistance range. The process 500 may follow a heuristic approach.Alternatively, the process 500 may search for the sequence of trajectorysegments that optimizes a certain target function, e.g. the sequencethat minimizes a weighted average of how far the requirements need to berelaxed, or the sequence that minimizes the angles between consecutivetrajectory segments. Any suitable optimization techniques known in theart may be used to optimize the sequence of trajectory segments for thechosen target function.

Other priorities or combinations of fixed and relaxed requirements arepossible. For example, the process 500 may keep all requirements fixedexcept the second trajectory segment being parallel to the central axisof the fossa ovalis. As illustrated in FIG. 3C, the second trajectorysegment may then be determined as the trajectory segment that connects apoint on the central inflow axis of the IVC 322, represented as acylinder, with a point on the deployment axis of the implantable device315, represented as a cylinder, and passes through the geometric centerpoint 370 of the fossa ovalis. This trajectory segment can be determinedby constructing a plane 372 through the central inflow axis of the IVC322 and the geometric center point 370 of the fossa ovalis, thendetermining the point 374 at which the deployment axis of theimplantable device 315 intersects this plane 372, then creating a linethrough this point 374 and the geometric center point 370 of the fossaovalis, then determining point 376 where this line intersects thecentral inflow axis of the IVC 322 and then creating a trajectorysegment that connects both intersection points 374 and 376.Alternatively, this trajectory segment can be determined by constructinga plane 378 through the deployment axis of the implantable device 315and the geometric center point 370 of the fossa ovalis, then determiningthe point 376 at which the central inflow axis of the implantable device322 intersects this plane 378, then creating a line through this point376 and the geometric center point 370 of the fossa ovalis, thendetermining point 374 where this line intersects the deployment axis ofthe implantable device 315 and then creating a trajectory segment thatconnects both intersection points 374 and 376. Alternatively, the sameresult can be obtained by constructing a first plane 372 through thecentral inflow axis of the IVC 322 and the geometric center point 370 ofthe fossa ovalis, constructing a second plane 378 through the deploymentaxis of the implantable device 315 and the geometric center point 370 ofthe fossa ovalis, determining the intersection line of these two planes,and creating a trajectory segment between the points 374 and 376 wherethis intersection line intersects with the central inflow axis of theIVC 322 and the deployment axis of the implantable device 315.

In some embodiments, determining a preferred trajectory for a catheterin block 508 may further comprise visualizing the preferred trajectoryin one or more of the one or more depictions of the anatomical region ofinterest. This may comprise overlaying onto one or more of the one ormore depictions a visual marker, such as a trajectory segment, a solidline, dashed line, dotted line, cylinder or the like for each of thetrajectory segments in the determined contiguous sequence of trajectorysegments. Optionally, the points between the trajectory segments may bevisualized as nodes, e.g. by overlaying onto one or more of the one ormore depictions visual markers, such as circles, squares, diamonds,spheres, cubes, etc.

In some embodiments, determining a preferred trajectory may furthercomprise manually editing the trajectory. This may, for example, beachieved by means of interactively moving one or part of any of thevisual markers described above.

In some embodiments, block 510 of generating, based on the preferredtrajectory, an execution plan may comprise evaluating for one or morecatheters or types of catheters whether or to what extent the preferredtrajectory can be achieved with that catheter. This may involvecomparing for a catheter the distances between its locations ofcontrolled bending with the lengths of the corresponding trajectorysegments of the preferred trajectory, and/or comparing for a catheterthe angles between consecutive trajectory segments with the ranges ofmotion of the catheter's corresponding locations of controlled bending.Alternatively or additionally, the block 510 may comprise computing fora catheter the trajectory that is still within the catheter'scapabilities and comes closest to the preferred trajectory, computing towhat extent its trajectory would have to deviate from the preferredtrajectory and optionally assigning a score based on that deviation,e.g. as a polynomial function of the angles and/or the differences inlength between corresponding sections of the preferred trajectory andthe catheter's closest-matching trajectory.

In some embodiments, block 510 may comprise loading from a file, adatabase or any kind of data carrier data relating to the one or morecatheters to be evaluated. Alternatively, it may comprise assigningvalues to the parameters of a generic parametric model of a catheter,such as number of locations of controlled bending, range of motion foreach bend, distance from the distal end to the first bend, distancesbetween consecutive bends, etc.

In some embodiments, evaluating one or more catheters or types ofcatheters may comprise retrieving from a database (e.g., database 106)data concerning one or more catheters or types of catheters. Such datamay comprise data describing the suitability of a catheter for theenvisaged catheter-based intervention. For example, if thecatheter-based intervention is the delivery of an implantable device,the data may describe the compatibility of the catheter with theimplantable device. The data may further comprise geometric data, suchas data describing the locations along the catheter of locations ofcontrolled bending, the distances between such locations of controlledbending and/or the ranges of motion at such locations of controlledbending. In some embodiments, evaluating one or more catheters orcatheter types may comprise selecting from a database of catheters onlythose catheters that are suitable for the envisaged catheter-basedintervention (e.g. those catheters compatible with the planned device tobe implanted) and evaluating each of those catheters. The outcome of theevaluation can, for example, be a list of suitable catheters or cathetertypes, or a list of catheters or catheter types, each with a scoredetermined as described above.

Block 510 may further comprise selecting, based on the evaluation, apreferred catheter. This selection may be performed by a user, such as amedical professional or a technically skilled user, such as a technicianor engineer, or may be fully automated based on pre-defined criteria.For example, the catheter with the highest or lowest score may beselected. If only one catheter has been evaluated, selecting a preferredcatheter may comprise either approving or declining it based on itsevaluation. The pre-defined criteria may include physician preferences,such as preferred supplier, preferred catheter type, etc.

Block 510 may further comprise generating an execution plan. Theexecution plan may comprise any combination of data relating to thepatient, the anatomical region of interest, the preferred catheter, thepreferred trajectory, the catheter's closest-matching trajectory, thecatheter's score, etc. An execution plan may be stored to a file. It maytake the format of a report. The report may comprise instructions forexecuting the catheter-based intervention, e.g. how many degrees to bendthe catheter at each location of controlled bending or how many degreesto twist the catheter between locations of controlled bending.Alternatively or additionally, it may be visualized on the display of acomputing device. Alternatively or additionally, it may serve as inputfor an intra-operative guidance system. For example, an intra-operativeimaging system may be equipped with the functionality to register datain the execution plan regarding the anatomical region of interest ontomedical images captured intra-operatively so as to overlay the preferredtrajectory or the catheter's closest-matching trajectory onto theintra-operative images. For example, the execution plan may serve asinput to a robotic surgical device. For anatomical parts that vary inshape over time, the execution plan may comprise data relating todifferent variations of shape, e.g. data relating to the systole anddata relating to the diastole.

In some embodiments, block 608 of selecting from a database one or morecatheters eligible for the catheter-based intervention may compriseconsulting a database (e.g., database 106) containing data concerningdifferent catheters or catheter types. The data may relate to any one ormore of the following: catheter brand, type, capabilities, eligibilityfor one or more catheter-based interventions, compatibility with one ormore implantable devices, etc. The data may contain an identification ofeach catheter and may describe the technical capabilities of eachcatheter. The technical capabilities may comprise one or more ofcatheter-specific geometric information, such as the catheter'sdimensions, the locations and shapes of any curves along its length, thelocations along its length where the catheter's operator may control itsbending and/or the range of motion and curvature of each of these bends.The database may also contain data pertaining to one or more implantabledevices. The data may contain an identification of each implantabledevice. The database may also contain compatibility data, describingwhich implantable devices are compatible with which catheters. Block 608may further comprise selecting, based on information regarding theenvisaged catheter-based intervention and data stored in the databaseone or more eligible catheters, e.g. catheters that might be suitablefor execution of the envisaged intervention. For example, if theenvisaged intervention is the delivery of an implantable device of acertain brand and type, the result of block 608 may be a list of allcatheters in the database that are compatible with the given brand andtype of implantable device.

In some embodiments, block 610 of for each of the one or more catheters,determining and optionally visualizing in one or more of the one or moredepictions a trajectory from the entry to the target may comprisedetermining for each of the catheters identified in block 608 aseligible one or more possible trajectories from the entry to the targetbased on the catheter-specific geometric information stored in thedatabase.

In some embodiments, determining a trajectory for a catheter in block610 comprises determining a contiguous sequence of trajectory segments.There may be one or more requirements with which, in an ideal situation,the sequence of trajectory segments complies. For example, the firsttrajectory segment may start at a determined entry point and be parallelto a determined entry direction, the final trajectory segment may end ata determined target point and be parallel to a determined targetdirection, and one or more trajectory segments may pass throughidentified local points of passage and/or be parallel to identifiedlocal directions of passage. For example, a first trajectory segment maystart at the IVC and may ideally coincide with the central inflow axisof the IVC, e.g. it has one endpoint in the center of the opening of theIVC in the right atrium and a direction tangential to the centrallongitudinal axis of the IVC at that point. For example, a secondtrajectory segment may ideally perforate the fossa ovalis at thegeometric center point of the fossa ovalis and may ideally be parallelto the central axis of the fossa ovalis, e.g. the axis through thegeometric center of the fossa ovalis and parallel to the normal vectorto the plane best fitting the fossa ovalis. For example, a thirdtrajectory segment may end at the planned position of an implantabledevice and may ideally be parallel to the deployment axis of theimplantable device. For example, all trajectory segments should be fullycontained within the blood pool volume of the heart, except for thesection where the second trajectory segment perforates the fossa ovalis.

In a typical situation, it may not be possible to reconcile all of theserequirements. Each of the one or more trajectories may therefore beevaluated against the requirements described above. For each of therequirements, the trajectory's deviation from the ideal situation may becomputed, e.g. as the angle between the IVC's central inflow axis andthe corresponding section of the catheter, the angle between the fossaovalis' central axis and the corresponding section of the catheter, theangle between the implantable device's deployment axis and thecorresponding section of the catheter, the shortest distance between thecenter of the opening of the IVC and the catheter, the distance betweenthe geometric center of the fossa ovalis and the point where thecatheter intersects the septum, the distance between the center point ofthe implantable device and the axis of the most distal section of thecatheter, etc. A target function may be defined as a polynomial functionof these deviations and a catheter-specific optimal trajectory may bedetermined by using any suitable optimizing algorithm known in the art.The coefficients of the polynomial function may penalize certaindeviations more than others. A score may be assigned to each trajectory,e.g. based on the value of the target function and for each eligiblecatheter a catheter-specific optimal trajectory may be selected based onthe score. Any suitable optimization techniques known in the art may beused to optimize the catheter-specific trajectory for the targetfunction and come to a catheter-specific optimal trajectory.

Limits may be set to the search space, e.g. by imposing maximum valuesto one or more of the computed deviations, and/or by monitoring that theentire trajectory is entirely contained within the blood pool volume ofthe right and left atrium. Catheters that are not able to follow atrajectory from the entry through imposed local points of passage to thetarget that is entirely contained within the blood pool volume may befiltered out.

In some embodiments, block 610 of for each of the one or more catheters,determining a trajectory from the entry to the target may furthercomprise visualizing in one or more of the one or more depictions atrajectory. Any of the trajectories mentioned above may be shown on thedisplay of a computing device in one or more of the one or moredepictions of the anatomical region of interest. A trajectory may bepresented by means of trajectory segments (e.g. shown as solid, dashedor dotted 2D lines, curves, cylinders or tubes), optionally connected bynodes (e.g. shown as circles, squares, diamonds, spheres, cubes, etc.).In some embodiments, the user may be allowed to interactively move nodesor trajectory segments in the visual representation. This movement maybe limited in any appropriate way or other parts of the trajectory maymove along (e.g. such that the trajectory remain contained in the bloodpool volume of the atria, such that the trajectory always pass throughthe fossa ovalis, such that a catheter-specific trajectory remain withinthe capabilities of the catheter, etc.).

In some embodiments, block 612 of generating, based on the one or moretrajectories, an execution plan may comprise selecting from the group ofeligible catheters a preferred catheter. This selection may be performedby a user, such as a medical professional or a technically skilled user,such as a technician or engineer, or may be fully automated based onpre-defined criteria. For example, the catheter with thecatheter-specific optimal trajectory with the highest score may beselected. If only one catheter has been evaluated, selecting a preferredcatheter may comprise either approving or declining it, e.g. based onthe score of its catheter-specific optimal trajectory. The pre-definedcriteria may include physician preferences, such as preferred supplier,preferred catheter type, etc.

Block 612 may further comprise generating an execution plan. Theexecution plan may comprise any combination of data relating to thepatient, the anatomical region of interest, the selected catheter, thecatheter's optimal trajectory, the trajectory's score, etc. An executionplan may be stored to a file. It may take the format of a report. Thereport may comprise instructions for executing the catheter-basedintervention, e.g. how many degrees to bend the catheter at eachlocation of controlled bending or how many degrees to twist the catheterbetween locations of controlled bending. Alternatively or additionally,it may be visualized on the display of a computing device. Alternativelyor additionally, it may serve as input for an intra-operative guidancesystem. For example, an intra-operative imaging system may be equippedwith the functionality to register data in the execution plan regardingthe anatomical region of interest onto medical images capturedintra-operatively so as to overlay the catheter's optimal trajectoryonto the intra-operative images. For example, the execution plan mayserve as input to a robotic surgical device. For anatomical parts thatvary in shape over time, the execution plan may comprise data relatingto different variations of shape, e.g. data relating to the systole anddata relating to the diastole.

In some embodiments, block 1308 of determining a trajectory from theentry to the target may comprise determining a trajectory as aparametric or piecewise parametric curve, as a sequence of one or moreline segments or as a combination of curves and line segments throughthe anatomical region of interest from the entry to the target via thelocal passages, if any. In certain embodiments, the number of trajectorysegments can be chosen freely by the user or can be a predeterminednumber, such as, for example, 1, 2, 3 or any other whole number. Incertain embodiments, the number may depend on the type of catheter-basedintervention or the types of available catheters. For example, if onlycatheters are available with n pre-determined bends, the number oftrajectory segments may be set at n+1.

In certain embodiments, if the determined entry defines a single pointof entry, the trajectory or its first trajectory segment may have astarting point coinciding with or close to the point of entry. Incertain embodiments, if the determined entry defines an area, the pointof entry may be a point within that area. In certain embodiments, if thedetermined entry also defines an entry direction, the trajectory or thefirst trajectory segment may be parallel or substantially parallel tothe entry direction in its starting point.

In certain embodiments, if the determined target defines a single point,the trajectory or its final trajectory segment may have an end pointcoinciding with or close to the target point. In certain embodiments, ifthe determined target defines an area, the end point may be a pointwithin that area. In certain embodiments, if the visualized target alsodefines a target direction, the trajectory or the final trajectorysegment may be parallel or substantially parallel to the targetdirection in its end point.

In some embodiments, determining a trajectory may comprise defining aparametric or piecewise parametric curve, such as a spline, from theentry point, through each of the local passage points, if any, to thetarget point. Determining a trajectory may further comprise defining theparametric or piecewise parametric curve such that it is parallel to theentry direction in the entry point, such that it is parallel to apassage direction in a passage point, and/or such that it is parallel tothe target direction in the target point.

In some embodiments, determining a preferred trajectory for a catheterin block 1308 may further comprise visualizing the preferred trajectoryin one or more of the one or more depictions of the anatomical region ofinterest. This may comprise overlaying onto one or more of the one ormore depictions a visual marker, such as a trajectory segment, a solidline, dashed line, dotted line, cylinder or the like for each of thetrajectory segments in the determined contiguous sequence of trajectorysegments. Optionally, the points between the trajectory segments may bevisualized as nodes, e.g. by overlaying onto one or more of the one ormore depictions visual markers, such as circles, squares, diamonds,spheres, cubes, etc.

In some embodiments, determining a preferred trajectory may furthercomprise manually editing the trajectory. This may, for example, beachieved by means of interactively moving one or part of any of thevisual markers described above.

In some embodiments, block 1310 of selecting, based on the preferredtrajectory, a catheter from a plurality of catheters may compriseevaluating for one or more catheters or types of catheters whether or towhat extent the catheter's pre-determined shape matches the preferredtrajectory. This may involve registering the catheter's pre-determinedshape onto the preferred trajectory. The registration may be based onthe catheter's centerline and the preferred trajectory, or on a surfacemodel of the catheter and a tubular surface obtained by sweeping thepreferred trajectory with a circle having the same diameter as thecatheter. The evaluation may further involve computing the deviationbetween the catheter's shape and the preferred trajectory and optionallyassigning a score based on that deviation.

In some embodiments, block 1310 may comprise loading from a file, adatabase or any kind of data carrier data relating to the one or morecatheters to be evaluated.

In some embodiments, evaluating one or more catheters or types ofcatheters may comprise retrieving from a database (e.g., database 106)data concerning one or more catheters or types of catheters. Such datamay comprise data describing the suitability of a catheter for theenvisaged catheter-based intervention. For example, if thecatheter-based intervention is the delivery of an implantable device,the data may describe the compatibility of the catheter with theimplantable device. The data may further comprise geometric data, suchas a surface model of the catheter, its centerline and/or its diameteror radius. In some embodiments, evaluating one or more catheters orcatheter types may comprise selecting from a database of catheters onlythose catheters that are suitable for the envisaged catheter-basedintervention (e.g. those catheters compatible with the planned device tobe implanted) and evaluating each of those catheters. The outcome of theevaluation can, for example, be a list of suitable catheters or cathetertypes, or a list of catheters or catheter types, each with a scoredetermined as described above.

In some embodiments, the evaluation may further comprise visualizing thecatheter in the one or more depictions of the anatomical region ofinterest, e.g., by means of a virtual surface model. The evaluation mayfurther comprise editing, by the user, the position of the catheter inthe anatomical region of interest. Limitations may be imposed on theediting capabilities. For example, if the entry comprises an entrydirection (e.g., the inflow axis of the IVC), only rotation around thisentry direction may be allowed. For example, if the entry comprises anarea (e.g., the opening of the IVC), only translation within this areamay be allowed.

Block 1310 may further comprise selecting, based on the evaluation, apreferred catheter. This selection may be performed by a user, such as amedical professional or a technically skilled user, such as a technicianor engineer, or may be fully automated based on pre-defined criteria.For example, the catheter with the highest or lowest score may beselected. If only one catheter has been evaluated, selecting a preferredcatheter may comprise either approving or declining it based on itsevaluation. The pre-defined criteria may include physician preferences,such as preferred supplier, preferred catheter type, etc. In someembodiments, the catheter is selected based on the deviation (e.g., thecatheter with the least deviation is selected, a catheter having lessthan a threshold deviation is selected, a catheter having less than athreshold deviation is selected that also meets another criteria (e.g.,material, cost, etc.)).

Optional block 1312 may comprise generating an execution plan. Theexecution plan may comprise any combination of data relating to thepatient, the anatomical region of interest, the preferred catheter, thepreferred trajectory, the catheter's score, etc. An execution plan maybe stored to a file. It may take the format of a report. The report maycomprise instructions for executing the catheter-based intervention,e.g. where to pierce the FO. Alternatively or additionally, it may bevisualized on the display of a computing device. Alternatively oradditionally, it may serve as input for an intra-operative guidancesystem. For example, an intra-operative imaging system may be equippedwith the functionality to register data in the execution plan regardingthe anatomical region of interest onto medical images capturedintra-operatively so as to overlay the preferred trajectory or thecatheter's shape onto the intra-operative images. For example, theexecution plan may serve as input to a robotic surgical device. Foranatomical parts that vary in shape over time, the execution plan maycomprise data relating to different variations of shape, e.g. datarelating to the systole and data relating to the diastole.

In some embodiments, the processes 500 and/or 600 and/or 1300 describedherein may further comprise an initial block (e.g., prior to block502/602/1302) of selecting one or more approaches. This selecting blockmay comprise selecting where the catheter should enter the patient'sbody and what route it should follow to reach the anatomical region ofinterest. For example, the user may choose one or more approaches fromthe group of transapical delivery, transseptal delivery through thefemoral artery and transseptal delivery through the subclavian artery.

When the user selects more than one approach, blocks 502-510 and/or602-612 and/or 1302-1312 may be repeated for each approach. Theprocesses 500 and/or 600 and/or 1300 described herein may then furthercomprise a final block (e.g., after block 510/612/1312) of selecting apreferred approach. This selecting block may comprise comparing theoutcomes of blocks 502-510 and/or 602-612 and/or 1302-1312 between thedifferent approaches and selecting one approach. The selection can bemade automatically, e.g. based on the score of each approach's preferredcatheter's catheter-specific optimal trajectory. The selection can alsobe made by a user, e.g. a technical user, such as a technician orengineer, e.g. based on the same objective criterion. The selection canalso be made by a medical professional, who can take additional medicalconcerns into consideration.

Instead of starting from data relating to a specific patient, thesystems and methods described herein may also be applied on statisticaldata. Various kinds of statistical models are known in the art, such asstatistical shape models, active shape models, active appearance modelsand the like. This allows users to evaluate the suitability of a certaincatheter type with respect to the broader patient population. Forexample, a user may use the systems or apply the methods on any instanceof a statistical model, such as an instance representing an averagepatient, or may investigate the 90th percentile of the population. Thismay help engineers design catheters that are suited for a larger part ofthe patient population or help develop families of particular cathetertypes in limited numbers of sizes. Blocks 502 and/or 602 and/or 1302 maythen further comprise creating one or more instances of a statisticalmodel, e.g. by selecting parameter values for the model's parametervector.

Alternatively, the systems and methods described herein may be appliedon a plurality of data sets, relating to a plurality of patients from acertain patient population.

It is to be understood that any feature described in relation to any oneembodiment may be used alone, or in combination with other featuresdescribed, and may also be used in combination with one or more featuresof any other of the embodiments, or any combination of any other of theembodiments. Furthermore, equivalents and modifications not describedabove may also be employed without departing from the scope of theinvention, which is defined in the accompanying claims.

The methods disclosed herein comprise one or more steps or actions forachieving the described method. The method steps and/or actions may beinterchanged with one another without departing from the scope of theclaims. In other words, unless a specific order of steps or actions isspecified, the order and/or use of specific steps and/or actions may bemodified without departing from the scope of the claims. Further, one ormore blocks/steps may be removed or added. For example, only portions ofprocess 500 and/or 600 and/or 1300 may be performed in certainembodiments.

Various embodiments disclosed herein provide for the use of a computersystem to perform certain features. A skilled artisan will readilyappreciate that these embodiments may be implemented using numerousdifferent types of computing devices, including both general-purposeand/or special-purpose computing system environments or configurations.Examples of well-known computing systems, environments, and/orconfigurations that may be suitable for use in connection with theembodiments set forth above may include, but are not limited to,personal computers, server computers, hand-held or laptop devices,multiprocessor systems, microprocessor-based systems, programmableconsumer electronics, network PCs, minicomputers, mainframe computers,distributed computing environments that include any of the above systemsor devices, and the like. These devices may include stored instructions,which, when executed by a microprocessor in the computing device, causethe computer device to perform specified actions to carry out theinstructions. As used herein, instructions refer to computer-implementedsteps for processing information in the system. Instructions can beimplemented in software, firmware or hardware and include any type ofprogrammed step undertaken by components of the system.

A microprocessor may be any conventional general-purpose single- ormulti-chip microprocessor such as a Pentium® processor, a Pentium® Proprocessor, an 8051 processor, a MIPS® processor, a Power PC® processor,or an Alpha® processor. In addition, the microprocessor may be anyconventional special-purpose microprocessor such as a digital signalprocessor or a graphics processor. The microprocessor typically hasconventional address lines, conventional data lines, and one or moreconventional control lines.

Aspects and embodiments of the inventions disclosed herein may beimplemented as a method, apparatus or article of manufacture usingstandard programming or engineering techniques to produce software,firmware, hardware, or any combination thereof. The term “article ofmanufacture” as used herein refers to code or logic implemented inhardware or non-transitory computer readable media such as opticalstorage devices, and volatile or non-volatile memory devices ortransitory computer readable media such as signals, carrier waves, etc.Such hardware may include, but is not limited to, field programmablegate arrays (FPGAs), application-specific integrated circuits (ASICs),complex programmable logic devices (CPLDs), programmable logic arrays(PLAs), microprocessors, or other similar processing devices.

What is claimed is:
 1. A computer-based method of planning acatheter-based intervention, the method comprising: obtaining, at acomputing device, a model of an anatomical region of interest;displaying, on the computing device, one or more depictions of theanatomical region of interest; determining, at the computing device, anentry in the anatomical region of interest; determining, at thecomputing device, a target in the anatomical region of interest;determining, at the computing device, a trajectory from the entry to thetarget; and selecting, at the computing device, a catheter from aplurality of catheters, wherein selecting the catheter comprises:registering a pre-determined shape of each of the plurality of cathetersonto the trajectory; for each of the plurality of catheters, displayingthe trajectory and the corresponding registered pre-determined shape inthe one or more depictions of the anatomical region of interest; andselecting, among the plurality of catheters, the catheter having thesmallest deviation between the registered corresponding pre-determinedshape and the trajectory.
 2. The method of claim 1, wherein thetrajectory comprises a parametric or piecewise parametric curve, asequence of straight line segments, or a combination of curves and linesegments.
 3. The method of claim 1, wherein registering, for each of theplurality of catheters, the pre-determined shape onto the trajectorycomprises: registering a centerline of said catheter onto thetrajectory; or registering a surface model of said catheter in thepre-determined shape onto a virtual tube obtained by sweeping a circlealong the trajectory.
 4. The method of claim 1, wherein the model of theanatomical region of interest comprises at least one of a virtual 3Dmodel of the anatomical region of interest or a medical image of theanatomical region of interest.
 5. The method of claim 1, wherein thecatheter comprises a device delivery sheath having one or morepredetermined bends.
 6. The method of claim 1, wherein determining thetrajectory comprises determining the trajectory based on one or moreconstraints, wherein the one or more constraints comprise one or moreoperational constraints indicating at least one or more positions withinthe anatomical region of interest through which the trajectory shouldpass or one or more tolerances with respect to the one or more positionsthrough which the trajectory should pass.
 7. The method of claim 6,wherein the one or more operational constraints comprise one or more of:at least a portion of the trajectory starting at a first feature of theanatomical region of interest and being tangential to an axis of thefirst feature within a first tolerance; at least a portion of thetrajectory perforating a second feature of the anatomical region ofinterest at a geometric center point of the second feature within asecond tolerance; at least a portion of the trajectory ending at thetarget and being parallel to an axis of the target within a thirdtolerance; or at least a portion of the trajectory ending at a geometriccenter point of a third feature of the anatomical region of interest andbeing parallel to a centerline of the third feature within a fourthtolerance.
 8. The method of claim 7, wherein: the first feature is aninferior vena cava (IVC) or a superior vena cava (SVC); the axis of thefirst feature comprises a central inflow axis of the IVC or SVC; thesecond feature is a fossa ovalis; the target comprises a plannedposition of an implantable device; the axis of the target comprises adeployment axis of the implantable device; and the third feature is anostium of a left atrial appendage.
 9. The method of claim 6, wherein theone or more constraints comprise the trajectory being fully containedwithin a blood pool volume of the anatomical region of interest exceptfor zero or more portions of the trajectory designated to perforate afeature of the anatomical region of interest.
 10. The method of claim 1,further comprising generating, at the computing device, based on theselected catheter, an execution plan comprising instructions forexecuting the catheter-based intervention using the catheter.
 11. Themethod of claim 1, wherein selecting the catheter further comprisesverifying that a pre-bent shape of the catheter matches the trajectorywithin a threshold.
 12. The method of claim 1, wherein the one or moredepictions of the anatomical region of interest are one or more of 2Dand 3D visualizations, and comprise one or more of a medical image, avolume rendering of medical images and a virtual 3D model.
 13. Themethod of claim 1, further comprising interactively moving at least oneof a node of the trajectory, a segment of the trajectory and a model ofthe pre-determined shape.
 14. A non-transitory computer-readable mediumhaving computer-executable instructions stored thereon, which, whenexecuted by one or more processors of a computing system, cause thecomputing system to perform a method of planning a catheter-basedintervention, the method comprising: obtaining a model of an anatomicalregion of interest; displaying one or more depictions of the anatomicalregion of interest; determining an entry in the anatomical region ofinterest; determining a target in the anatomical region of interest;determining a trajectory from the entry to the target; and selecting acatheter from a plurality of catheters, wherein selecting the cathetercomprises: registering a pre-determined shape of each of the pluralityof catheters onto the trajectory; for each of the plurality ofcatheters, displaying the trajectory and the corresponding registeredpre-determined shape in the one or more depictions of the anatomicalregion of interest; and selecting, among the plurality of catheters, thecatheter having the smallest deviation between the registeredcorresponding pre-determined shape and the trajectory.
 15. Thenon-transitory computer-readable medium of claim 14, whereinregistering, for each of the plurality of catheters, the pre-determinedshape onto the trajectory comprises: registering a centerline of saidcatheter onto the trajectory; or registering a surface model of saidcatheter in the pre-determined shape onto a virtual tube obtained bysweeping a circle along the trajectory.
 16. The non-transitorycomputer-readable medium of claim 14, wherein the model of theanatomical region of interest comprises at least one of a virtual 3Dmodel of the anatomical region of interest or a medical image of theanatomical region of interest.
 17. The non-transitory computer-readablemedium of claim 14, wherein the catheter comprises a device deliverysheath having one or more predetermined bends.
 18. A computing devicecomprising: memory; and one or more processors configured to perform amethod of planning a catheter-based intervention, the method comprising:obtaining a model of an anatomical region of interest; displaying one ormore depictions of the anatomical region of interest; determining anentry in the anatomical region of interest; determining a target in theanatomical region of interest; determining a trajectory from the entryto the target; and selecting a catheter from a plurality of catheters,wherein selecting the catheter comprises: registering a pre-determinedshape of each of the plurality of catheters onto the trajectory; foreach of the plurality of catheters, displaying the trajectory and thecorresponding registered pre-determined shape in the one or moredepictions of the anatomical region of interest; and selecting, amongthe plurality of catheters, the catheter having the smallest deviationbetween the registered corresponding pre-determined shape and thetrajectory.
 19. The non-transitory computer-readable medium of claim 18,wherein registering, for each of the plurality of catheters, thepre-determined shape onto the trajectory comprises: registering acenterline of said catheter onto the trajectory; or registering asurface model of said catheter in the pre-determined shape onto avirtual tube obtained by sweeping a circle along the trajectory.
 20. Thenon-transitory computer-readable medium of claim 18, wherein the modelof the anatomical region of interest comprises at least one of a virtual3D model of the anatomical region of interest or a medical image of theanatomical region of interest.